| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00854763005792 | EPFU-W | EPFU-W | Uncoated Epifoam Adhesive Wrap (1 wrap) 36"x 11.75"x 0.375" | MDA | Elastomer, Silicone, For Scar Management | 1 | EPI-FOAM |
| 2 | 00854763005778 | EPF-W | EPF-3 | Epifoam Adhesive Wrap (1 Wrap ) 36"x 11.75"x 0.375" | MDA | Elastomer, Silicone, For Scar Management | 1 | EPI-FOAM |
| 3 | 00854763005761 | EPF-1 | EPF-1 | EpIfoam Silicone-Backed Adhesive Pad (1 pad per pouch) | MDA | Elastomer, Silicone, For Scar Management | 1 | EPI-FOAM |
| 4 | 00854763005754 | EPFU-1 | EPFU-1 | Epifoam Uncoated Pads (1 pad per pouch). | MDA | Elastomer, Silicone, For Scar Management | 1 | EPI-FOAM |
| 5 | 00854763005549 | EPFU-W6 | EPFU-W6 | Uncoated Epifoam Adhesive Wrap (6 wraps per case) 36"x 11.75"x 0.375" | MDA | Elastomer, Silicone, For Scar Management | 1 | EPI-FOAM |
| 6 | 00854763005532 | EPFU-30 | EPFU-30 | Epifoam Uncoated Pads (30 pads per case). | MDA | Elastomer, Silicone, For Scar Management | 1 | EPI-FOAM |
| 7 | 00854763005525 | EPFU-3 | EPFU-3 | Epifoam Uncoated Pads (3 pads per pouch) | MDA | Elastomer, Silicone, For Scar Management | 1 | EPI-FOAM |
| 8 | 00854763005921 | SCSKT17-111 | SCSKT17-111 | Scar Aid Kids Silicone Stick, 17g | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 9 | 00854763005914 | SCSKT-111 | SCSKT-111 | Scar Aid Kids Silicone Stick, 4.25g | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 10 | 00854763005907 | SCST17-111 | SCST17-111 | Scar Aid Silicone Stick, 17g | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 11 | 00854763005891 | SCST-111 | SCST-111 | Scar Aid Stick, 4.25g | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 12 | 00854763005884 | SCSO-797 | SCSO-797 | Scar Aid Ointment Tube 10g | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 13 | 00854763005976 | SFG-N30 | SFG-N30 | Scar Aid Fabric 6 Up, 30 Sheets 2.75" x 1.18", | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 14 | 00854763005969 | SFG-N15 | SFG-N15 | Scar Aid Fabric, 3 Up, 15 Pack 2.75" x 1.18" | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 15 | 00854763005945 | SCSTSP17-111 | SCSTSP17-111 | Scar Aid SPF 15 Silicone Stick, 17g | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 16 | 00854763005938 | SCSTSP-111 | SCSTSP-111 | Scar Aid SPF 15 Silicone Stick, 4.25g | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 17 | 00854763005747 | SCS-51 | SCS-51 | Scar Aid EpiTab Squares 30-Pack 1.25" x 1.25" | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 18 | 00854763005730 | SCC-51 | SCC-51 | Scar Aid EpiTab Circles 30-Pack 1.90 cm Diam. | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 19 | 00854763005723 | SCS-1 | SCS-1 | Scar Aid EpiTab Squares 6-Pack 1.25" x 1.25" | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 20 | 00854763005716 | SCC-1 | SCC-1 | Scar Aid EpiTab Circles 6-Pack 1.90 cm Diam. | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 21 | 00854763005709 | SCLP-51 | SCLP-51 | Scar Aid Areopexy 2.75" OD x .75 ID x 5.90" L, 5 Pair | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 22 | 00854763005693 | SCLP-1 | SCLP-1 | Scar Aid Areopexy 2.75" OD x .75 ID x 5.90" L | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 23 | 00854763005686 | SCG-1106 | SCG-1106 | Scar Aid C-Strip 1.4" x 6.0" | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 24 | 00854763005679 | SCG-5106 | SCG-5106 | Scar Aid C-Strip 1.4" x 6.0", 5 Pack | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 25 | 00854763005662 | SCAC-51 | SCAC-51 | Scar Aid Areola Circles 3" x 0.75", 5 Pack | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 26 | 00854763005655 | SCMP-51 | SCMP-51 | Scar Aid Mastopexy-L/R 12.6" x 3.8" | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 27 | 00854763005648 | SCG-5116 | SCG-5116 | Scar Aid Large 11" x 15.75", 5 Pack. | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 28 | 00854763005631 | SCG-5112 | SCG-5112 | Scar Aid Strip 1.4" x 11.5", 5 Pack | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 29 | 00854763005624 | SCG-5123 | SCG-5123 | Scar Aid Patch 2" x 2.5", 5 Pack | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 30 | 00854763005617 | SCAC-1 | SCAC-1 | Scar Aid Areola Circles 3" x 0.75", 1 Pair | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 31 | 00854763005600 | SCMP-1 | SCMP-1 | Scar Aid Mastopexy L/R 12.6" x 3.8" | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 32 | 00854763005594 | SCG-1116 | SCG-1116 | Scar Aid Large Sheet 11" x 15.75" | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 33 | 00854763005587 | SCG-1112 | SCG-1112 | Scar Aid Strip 1.4" x 11.5" | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 34 | 00854763005570 | SCG-123 | SCG-123 | Scar Aid Patch 2" x 2.5" | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 35 | 00854763005563 | SCG-146 | SCG-146 | Scar Aid Standard sheet 4.7" x 5.7" | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 36 | 00854763005556 | SCG-46 | SCG-46 | Scar Aid Standard sheet 4.7" x 5.7", 5 Pack | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 37 | 00854763005266 | SFG-5106 | SFG-5106 | Scar Aid Fabric C-Strip 1.4" x 6.0", 5 Strips | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 38 | 00854763005259 | SFG-1106 | SFG-1106 | Scar Aid Fabric C-Strip 1.4" x 6.0", 1 Strip | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 39 | 00854763005204 | SFG-N6 | SFG-N6 | Scar Aid Fabric, 6 Up Sheets 2.75" x 1.18", 6 sheets per box. | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 40 | 00854763005198 | SFG-N3 | SFG-N3 | Scar Aid Fabric, 3 Up Sheets 2.75" x 1.18", 3 sheets per box. | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 41 | 00854763005181 | SFMP-51 | SFMP-51 | Scar Aid Fabric Mastopexy-L/R 12.6" x 3.8", 5 Pair | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 42 | 00854763005174 | SFMP-1 | SFMP-1 | Scar Aid Fabric Mastopexy-L/R 12.6" x 3.8", 1 pair | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 43 | 00854763005167 | SFLP-51 | SFLP-51 | Scar Aid Fabric Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 5 pair | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 44 | 00854763005150 | SFLP-1 | SFLP-1 | Scar Aid Fabric Areopexy 2.75" OD x .75 ID x 5.90" L (6.9cm OD x 1.9cm ID) 1 pair | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 45 | 00854763005143 | SFAC-51 | SFAC-51 | Scar Aid Fabric Areola Circles, 3" x 0.75", 5 Pair | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 46 | 00854763005136 | SFAC-1 | SFAC-1 | Scar Aid Fabric Areola Circles 3" x 0.75", 1 Pair | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 47 | 00854763005129 | SFT-S51 | SFT-S51 | Scar Aid Fabric EpiTab Squares 30-Pack 1.25" x 1.25" | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 48 | 00854763005112 | SFT-S | SFT-S | Scar Aid Fabric EpiTab Squares 6-Pack 1.25" x 1.25" | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 49 | 00854763005105 | SFT-C51 | SFT-C51 | Scar Aid Fabric EpiTab Circles 30-Pack 1.90 cm Diam. | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| 50 | 00854763005099 | SFT-C | SFT-C | Scar Aid Fabric EpiTab Circles 6-Pack 1.90 cm Diam. | MDA | Elastomer, Silicone, For Scar Management | 1 | SCAR AID |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00642790850153 | 85015 | 85015 | ScarSil Silicone Scar Gel 15 ml | ScarSil | SCAR HEAL |
| 2 | 00642790850009 | 85000 | 85000 | ScarSil Silicone Scar Gel 30 ml | ScarSil | SCAR HEAL |
| 3 | 00642790800158 | 80015 | 80015 | RejuvaSil Silicone Scar Gel 15 ml | RejuvaSil | SCAR HEAL |
| 4 | 00642790800103 | 80010 | 80010 | RejuvaSil Silicone Scar Gel 10 ml | RejuvaSil | SCAR HEAL |
| 5 | 00642790800004 | 80000 | 80000 | RejuvaSil Silicone Scar Gel 30 ml | RejuvaSil | SCAR HEAL |
| 6 | 00642790156781 | 15678 | 15678 | Scar Fx Silicone Sheeting Breast Anchor | Scar Fx | SCAR HEAL |
| 7 | 00642790134567 | 13456 | 13456 | Scar Fx Silicone Sheeting Lollipop Breast Piece | Scar Fx | SCAR HEAL |
| 8 | 00642790115092 | 11509 | 11509 | Scar Fx Silicone Sheeting 1.5"x9" | Scar Fx | SCAR HEAL |
| 9 | 00642790115054 | 11505 | 11505 | Scar Fx Silicone Sheeting 1.5"x5" | Scar Fx | SCAR HEAL |
| 10 | 00642790115030 | 11503 | 11503 | Scar Fx Silicone Sheeting 1.5"x3" | Scar Fx | SCAR HEAL |
| 11 | 00642790112343 | 11234 | 11234 | Scar Fx Silicone Sheeting Breast Piece | Scar Fx | SCAR HEAL |
| 12 | 00642790110127 | 11012 | 11012 | Scar Fx Silicone Sheeting 10"x12" | Scar Fx | SCAR HEAL |
| 13 | 00642790106489 | 10648 | 10648 | Gelzone garment belt with silicone sheeting 6"x48" | Scar Fx | SCAR HEAL |
| 14 | 00642790104089 | 10408 | 10408 | Scar Fx Silicone Sheeting 4"x8" | Scar Fx | SCAR HEAL |
| 15 | 00642790103051 | 10305 | 10305 | Scar Fx Silicone Sheeting 3"x5" | Scar Fx | SCAR HEAL |
| 16 | 00642790101224 | 10122 | 10122 | Scar Fx Silicone Sheeting 1"x22" | Scar Fx | SCAR HEAL |
| 17 | 00642790101125 | 10112 | 10112 | Scar Fx Silicone Sheeting 1"x12" | Scar Fx | SCAR HEAL |
| 18 | 00642790100005 | 10000 | 10000 | Scar Fx Silicone Sheeting 3" Breast Circle | Scar Fx | SCAR HEAL |
| 19 | 00385640033367 | SP-66150 | SILICONE SHEETING | SUMMIT MEDICAL, INC. | ||
| 20 | 00385640033350 | SP-66100 | SILICONE SHEETING | SUMMIT MEDICAL, INC. | ||
| 21 | 00385640033343 | SP-66050 | SILICONE SHEETING | SUMMIT MEDICAL, INC. | ||
| 22 | 00385640033336 | SP-66025 | SILICONE SHEETING | SUMMIT MEDICAL, INC. | ||
| 23 | 00385640033329 | SP-66012 | SILICONE SHEETING | SUMMIT MEDICAL, INC. | ||
| 24 | 00385640000116 | SP-65100 | SP-65100 | Silicone Sheeting | SUMMIT MEDICAL, INC. | |
| 25 | 00385640000109 | SP-65000 | SP-65000 | Silicone Sheeting | SUMMIT MEDICAL, INC. | |
| 26 | 00372380000384 | Silinoin | A non-sterile covering made of a silicone-based material (e.g., silicone gel) in A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning. | Vivera Pharmaceuticals, Inc | VIVERA PHARMACEUTICALS, INC. | |
| 27 | 00372380000322 | Szosil | A non-sterile covering made of a silicone-based material (e.g., silicone gel) in A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning. | Vivera Pharmaceuticals | VIVERA PHARMACEUTICALS, INC. | |
| 28 | 00372380000315 | Szosil | A non-sterile covering made of a silicone-based material (e.g., silicone gel) in A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning. | Vivera Pharmaceuticals | VIVERA PHARMACEUTICALS, INC. | |
| 29 | 00372380000032 | 1 | szosil skin repair serum | VIVERA PHARMACEUTICALS, INC. | ||
| 30 | 00372380000025 | 1 | szosil silicone stick | VIVERA PHARMACEUTICALS, INC. | ||
| 31 | 00372380000018 | 1 | szosil medical grade silicone gel sheeting for scar | VIVERA PHARMACEUTICALS, INC. | ||
| 32 | 00311917212159 | 549675 | WALG LARGE SILICONE SCAR SHEETS 6CT | Walgreens | WALGREEN CO. | |
| 33 | 00311917174549 | 385894 | WALG SILICONE SCAR SHEET CLEAR 8S | Walgreens | WALGREEN CO. | |
| 34 | 00070030511739 | 11A3QSAC1 | PC: 11A | SCARAWAY SILICONE GEL 20G | L PERRIGO COMPANY | |
| 35 | 30884389103184 | CUR02063 | CUR02063 | DBD-BANDAGE,SCAR THERAPY,CURAD,2.6X1.5,2 | Curad | MEDLINE INDUSTRIES, INC. |
| 36 | 15060295491220 | 3g | SDSCRSAM-3G | Silicone Scar Gel Sachets packed in laminet. | SilDerm Scar Gel Sachet | SKINGEN UK LTD |
| 37 | 15060295490179 | 15g | SDSCRDA15UK | Silicone Scar Gel packed in tubes made of linear low HDPE/LDPE blend plastic tub Silicone Scar Gel packed in tubes made of linear low HDPE/LDPE blend plastic tube with three roller balls and a Plain white screw cap type | SilDerm Dual Action Scar Gel | SKINGEN UK LTD |
| 38 | 15060295490100 | 60ml | SDSCR60 | Silicone Scar Spray in bottles made from zylinderfl.60, glasklar PETG, 5g, M300 Silicone Scar Spray in bottles made from zylinderfl.60, glasklar PETG, 5g, M300 smooth white Spray head. Label material white PP with UV gloss varnish | SilDerm Scar Spray | SKINGEN UK LTD |
| 39 | 15060295490094 | 30ml | SDSCRS30 | Silicone Scar Spray in bottles made of zylinderfl.60, glasklar PETG, 5g, M300 sm Silicone Scar Spray in bottles made of zylinderfl.60, glasklar PETG, 5g, M300 smooth white Spray head. Label material white PP with UV gloss varnish | SilDerm Scar Spray | SKINGEN UK LTD |
| 40 | 15060295490056 | 6g | SDSCR6UK | Silicone Scar Gel packed in tubes made of linear low HDPE/LDPE blend plastic tub Silicone Scar Gel packed in tubes made of linear low HDPE/LDPE blend plastic tube Plain white screw cap type | SilDerm Scar Gel | SKINGEN UK LTD |
| 41 | 15060295490032 | 15g | SDSCR15UK | Silicone Scar Gel packed in tubes made of linear low HDPE/LDPE blend plastic tub Silicone Scar Gel packed in tubes made of linear low HDPE/LDPE blend plastic tube Plain white screw cap type | SilDerm Scar Gel | SKINGEN UK LTD |
| 42 | 15060295490001 | 10ml | SDSCRS10 | Silicone Scar Spray in bottles made of zylinderfl.30, glasklar PETG, 5g, M300 sm Silicone Scar Spray in bottles made of zylinderfl.30, glasklar PETG, 5g, M300 smooth white Spray head. Label material white PP with UV gloss varnish. | SilDerm Scar Spray | SKINGEN UK LTD |
| 43 | 14719745504324 | SC201-2 | Anscare Scar Reduction Silicone Gel C+ helps prevent and treat both existing and Anscare Scar Reduction Silicone Gel C+ helps prevent and treat both existing and new scars like keloids and hypertrophic scars resulting from surgery, trauma, burns, etc. (External Use Only) | Anscare Scar Reduction Silicone Gel C+ | BENQ MATERIALS CORP. | |
| 44 | 14719745503006 | SC201-1 | Anscare Scar Reduction Silicone Gel C+ helps prevent and treat both existing and Anscare Scar Reduction Silicone Gel C+ helps prevent and treat both existing and new scars like keloids and hypertrophic scars resulting from surgery, trauma, burns, etc. (External Use Only) | Anscare Scar Reduction Silicone Gel C+ | BENQ MATERIALS CORP. | |
| 45 | 14719745020879 | SP-14-1112 | Anscare Leniscar Silicone Stick provides an easy-to-use topical scar treatment. Anscare Leniscar Silicone Stick provides an easy-to-use topical scar treatment. It is intended to diminish hypertrophic scars and keloids characterized with a raised or discolored appearance. LeniScar is an advanced silicone formula which contains medical grade silicone and antioxidant vitamin C & E. It creates a waterproof, transparent thinfilm which helps to maintain the moisture balance of skin and provides an optimal protective barrier for the scar to restore. | Anscare LeniScar Silicone Stick | BENQ MATERIALS CORP. | |
| 46 | 14719745020855 | SP-14-1111 | Anscare Leniscar Silicone Stick provides an easy-to-use topical scar treatment. Anscare Leniscar Silicone Stick provides an easy-to-use topical scar treatment. It is intended to diminish hypertrophic scars and keloids characterized with a raised or discolored appearance. LeniScar is an advanced silicone formula which contains medical grade silicone and antioxidant vitamin C & E. It creates a waterproof, transparent thinfilm which helps to maintain the moisture balance of skin and provides an optimal protective barrier for the scar to restore. | Anscare LeniScar Silicone Stick | BENQ MATERIALS CORP. | |
| 47 | 14711182628779 | SA042501 | Rystora® Scar Sheets | FORTUNE MEDICAL INSTRUMENT CORP. | ||
| 48 | 14711182628762 | SA050701 | Rystora® Scar Sheets | FORTUNE MEDICAL INSTRUMENT CORP. | ||
| 49 | 14711182628755 | SA101801 | Rystora® Scar Sheets | FORTUNE MEDICAL INSTRUMENT CORP. | ||
| 50 | 14711182607026 | SA101812 | Rystora® Scar Sheets | FORTUNE MEDICAL INSTRUMENT CORP. |