No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850029191230 | 21001 | Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70 | 3A MEDICAL | ||||
2 | 00850029191223 | 31001 | Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets re Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
3 | 00850029191216 | 3AJS0001 | ULTRA Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70 ULTRA Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
4 | 00850029191209 | 21001 | Standard Surgical gown, Size LARGE , SINGLE USE ONLY, LEVEL 2 AAMI PB70 | 3A MEDICAL | ||||
5 | 00850029191193 | S4005 | Poly Reinforced Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70 Poly Reinforced Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
6 | 00850029191186 | S4004 | Poly Reinforced Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70, Poly Reinforced Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
7 | 00850029191179 | S4003 | Poly Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,M Poly Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
8 | 00850029191162 | S4002 | Poly Reinforced Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AAMI PB70, Poly Reinforced Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
9 | 00850029191148 | S3005 | Standard Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets r Standard Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
10 | 00850029191131 | S3004 | Standard Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets re Standard Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
11 | 00850029191124 | S3003 | Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets req Standard Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
12 | 00850029191117 | S3002 | Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets r Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
13 | 00850029191100 | S3001 | Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets req Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
14 | 00850029191094 | S4005 | Poly Reinforced Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70 Poly Reinforced Surgical gown, Size XXLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
15 | 00850029191087 | S4004 | Poly Reinforced Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70, Poly Reinforced Surgical gown, Size XLARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
16 | 00850029191070 | S4003 | Poly Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,M Poly Reinforced Surgical gown, Size LARGE, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
17 | 00850029191063 | S4002 | Poly Reinforced Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AAMI PB70, Poly Reinforced Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
18 | 00850029191056 | S4001 | Poly Reinforced Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAMI PB70,M Poly Reinforced Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 4 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
19 | 00850029191018 | S3002 | Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets r Standard Surgical gown, Size MEDIUM, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
20 | 00850029191001 | S3001 | Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets req Standard Surgical gown, Size SMALL, SINGLE USE ONLY, LEVEL 3 AAMI PB70,Meets requirement of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A MEDICAL | |
21 | 00850029191049 | S3005 | Standard Surgical Gown, Size XX-Large. Sterile. Single Use Only. Level 3 AAMI PB Standard Surgical Gown, Size XX-Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requirements of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A Medical | |
22 | 00850029191032 | S3004 | Standard Surgical Gown, Size X-Large. Sterile. Single Use Only. Level 3 AAMI PB7 Standard Surgical Gown, Size X-Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requirements of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A Medical | |
23 | 00850029191025 | S3003 | Standard Surgical Gown, Size Large. Sterile. Single Use Only. Level 3 AAMI PB70. Standard Surgical Gown, Size Large. Sterile. Single Use Only. Level 3 AAMI PB70. Meets requirements of ASTM F2407 | FYA | Gown, Surgical | 2 | 3A Medical |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08809783490297 | SG-P2004NS-XXL | Unico Global Level 3 Surgical Gown (PP+PE) | UNICO GLOBAL INC | ||
2 | 08809783490280 | SG-P2004NS-XL | Unico Global Level 3 Surgical Gown (PP+PE) | UNICO GLOBAL INC | ||
3 | 08809783490273 | SG-P2004NS-L | Unico Global Level 3 Surgical Gown (PP+PE) | UNICO GLOBAL INC | ||
4 | 08809783490266 | SG-P2004NS-M | Unico Global Level 3 Surgical Gown (PP+PE) | UNICO GLOBAL INC | ||
5 | 08809783490259 | SG-P2004NS-S | Unico Global Level 3 Surgical Gown (PP+PE) | UNICO GLOBAL INC | ||
6 | 08809783490242 | SG-P2003S-XXL | Unico Global Level 3 Surgical Gown (PP+PE) | UNICO GLOBAL INC | ||
7 | 08809783490235 | SG-P2003S-XL | Unico Global Level 3 Surgical Gown (PP+PE) | UNICO GLOBAL INC | ||
8 | 08809783490228 | SG-P2003S-L | Unico Global Level 3 Surgical Gown (PP+PE) | UNICO GLOBAL INC | ||
9 | 08809783490211 | SG-P2003S-M | Unico Global Level 3 Surgical Gown (PP+PE) | UNICO GLOBAL INC | ||
10 | 08809783490204 | SG-P2003S-S | Unico Global Level 3 Surgical Gown (PP+PE) | UNICO GLOBAL INC | ||
11 | 08809783490198 | SG-S2002NS-XXL | Unico Global Level 3 Surgical Gown (Film-Reinforced SMS) | UNICO GLOBAL INC | ||
12 | 08809783490181 | SG-S2002NS-XL | Unico Global Level 3 Surgical Gown (Film-Reinforced SMS) | UNICO GLOBAL INC | ||
13 | 08809783490174 | SG-S2002NS-L | Unico Global Level 3 Surgical Gown (Film-Reinforced SMS) | UNICO GLOBAL INC | ||
14 | 08809783490167 | SG-S2002NS-M | Unico Global Level 3 Surgical Gown (Film-Reinforced SMS) | UNICO GLOBAL INC | ||
15 | 08809783490150 | SG-S2002NS-S | Unico Global Level 3 Surgical Gown (Film-Reinforced SMS) | UNICO GLOBAL INC | ||
16 | 08809783490143 | SG-S2001S-XXL | Unico Global Level 3 Surgical Gown (Film-Reinforced SMS) | UNICO GLOBAL INC | ||
17 | 08809783490136 | SG-S2001S-XL | Unico Global Level 3 Surgical Gown (Film-Reinforced SMS) | UNICO GLOBAL INC | ||
18 | 08809783490129 | SG-S2001S-L | Unico Global Level 3 Surgical Gown (Film-Reinforced SMS) | UNICO GLOBAL INC | ||
19 | 08809783490112 | SG-S2001S-M | Unico Global Level 3 Surgical Gown (Film-Reinforced SMS) | UNICO GLOBAL INC | ||
20 | 08809783490105 | SG-S2001S-S | Unico Global Level 3 Surgical Gown (Film-Reinforced SMS) | UNICO GLOBAL INC | ||
21 | 08683105129450 | PSM104-2XL | STERILE GOWN | Puresense Med | PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI | |
22 | 08683105129443 | PSM104-XL | STERILE GOWN | Puresense Med | PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI | |
23 | 08683105129436 | PSM104-L | STERILE GOWN | Puresense Med | PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI | |
24 | 08683105129429 | PSM104-M | STERILE GOWN | Puresense Med | PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI | |
25 | 08683105129412 | PSM104-S | STERILE GOWN | Puresense Med | PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI | |
26 | 08683105129351 | PSM103-2XL | STERILE GOWN | Puresense Med | PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI | |
27 | 08683105129344 | PSM103-XL | STERILE GOWN | Puresense Med | PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI | |
28 | 08683105129337 | PSM103-L | STERILE GOWN | Puresense Med | PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI | |
29 | 08683105129320 | PSM103-M | STERILE GOWN | Puresense Med | PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI | |
30 | 08683105129313 | PSM103-S | STERILE GOWN | Puresense Med | PURESENSE PRODUCTS MEDIKAL URUNLERI ITHALAT IHRACAT LIMITED SIRKETI | |
31 | 08056646502462 | 30.D2304.00 | ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE XXL | ESSENTIAL SURGICAL | OMNIA SRL | |
32 | 08056646502455 | 30.D2303.00 | ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE XL | ESSENTIAL SURGICAL | OMNIA SRL | |
33 | 08056646502448 | 30.D2302.00 | ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE L | ESSENTIAL SURGICAL | OMNIA SRL | |
34 | 08056646502431 | 30.D2301.00 | ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE M | ESSENTIAL SURGICAL | OMNIA SRL | |
35 | 08056646500840 | 12.XYYYY.00 | The sterile "Procedural Packages for Diagnosis and Surgery" are intended for use The sterile "Procedural Packages for Diagnosis and Surgery" are intended for use by specialized personnel and are composed of consumables and devices intended for the preparation of the operating field, maintenance of cleanliness (ensuring the hygiene of the field and limiting the risk of contamination) and the performance of various types of surgery.The devices provided can be:- non-invasive devices, for the preparation of the operating field - for example: drapes, gowns, masks and accessories (bandages, sheaths, tool pockets, bags for collecting liquids, fixed pliers for drapes, etc.)- invasive surgical devices for temporary use not in contact with the central circulatory system and with the nervous system - for example: needles and syringes with needle, disposable scalpels and gauze.- devices for channeling liquids intended for irrigation.Possible combination of any of the devices mentioned are identified with different UDI code listed in the section "Package DI" Model number : X = alphabetic character YYYY=n° of 4 number character. | Implant Kit | OMNIA SRL | |
36 | 08056646500222 | 12.XYYYY.00 | Indication For Use: Surgical Procedure Packs is a kit for oral implantology, use Indication For Use: Surgical Procedure Packs is a kit for oral implantology, used by dental professionals when performing surgical procedures. Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries.Surgical Procedure Packs may be packages as a combination of any of the following components: - Surgical gowns (various models) with or without hand towels- Surgical Drapes:- Mayo drape- Absorbent/liquid proof drapes (with or without adhesive)- Adhesive side drape- Liquid repellent drape with or without adhesive- Face mask- Protective caps- Sheath/tubing sleeve- Surgical aspirator with adaptor- Surgical gauze- Disinfection sponge and/or basin- Adhesive films- Syringe- Needles- Single-use scalpel- Small dental mirror/dental explorer/tweezer- Irrigation/infusion line- Stopcock and ramp for infusion- Waste bag for contaminated material- Bone collector- Saliva ejector- Basin- Medical paperPossible combination of any of the devices mentioned are identified with different UDI code listed in the section "Package DI"Model Number:X = alphabetic characterYYYY= n° of 4 number character | SURGICAL PROCEDURE PACK | OMNIA SRL | |
37 | 07613327520279 | 0408800200 | 0408-800-200 | Hood, S95 | Flyte | STRYKER CORPORATION |
38 | 07613327466133 | 0416-851-100 | 0416-851-100 | Zippered Toga with Peel Away Face Shield | T7Plus | STRYKER CORPORATION |
39 | 07613327466126 | 0416-820-100 | 0416-820-100 | Zippered Toga with Peel Away Face Shield | T7 | STRYKER CORPORATION |
40 | 07613327466119 | 0416-851-200 | 0416-851-200 | Zippered Toga | T7Plus | STRYKER CORPORATION |
41 | 07613327466102 | 0416-831-100 | 0416-831-100 | Zippered Toga with Peel Away | T7Plus | STRYKER CORPORATION |
42 | 07613327466096 | 0416-840-100 | 0416-840-100 | Zippered Toga with Peel Away Face Shield | T7 | STRYKER CORPORATION |
43 | 07613327466089 | 0416-830-100 | 0416-830-100 | Zippered Toga with Peel Away Face Shield | T7 | STRYKER CORPORATION |
44 | 07613327466072 | 0416-741-200 | 0416-741-200 | Pullover Toga | T7Plus | STRYKER CORPORATION |
45 | 07613327466065 | 0416-731-200 | 0416-731-200 | Pullover Toga | T7Plus | STRYKER CORPORATION |
46 | 07613327466058 | 0416-840-200 | 0416-840-200 | Zippered Toga | T7 | STRYKER CORPORATION |
47 | 07613327466041 | 0416-720-200 | 0416-720-200 | Pullover Toga | T7 | STRYKER CORPORATION |
48 | 07613327466034 | 0416-820-200 | 0416-820-200 | Zippered Toga | T7 | STRYKER CORPORATION |
49 | 07613327466027 | 0416-841-100 | 0416-841-100 | Zippered Toga with Peel Away Face Shield | T7Plus | STRYKER CORPORATION |
50 | 07613327466010 | 0416-821-100 | 0416-821-100 | Zippered Toga with Peel Away Face Shield | T7Plus | STRYKER CORPORATION |