No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10814707020004 | 14410 | FLUIDGARD ® 160 ANTI-FOG PROCEDURE MASK WITH EXTENDED SHIELD | FXX | Mask, Surgical | Precept ® | ||
2 | 00814707020700 | 6601 | Patient Welcome Kit | LRO | General Surgery Tray | Precept® | ||
3 | 00814707020564 | 0079 | FATHERS KIT | LRO | General Surgery Tray | 2 | Precept® | |
4 | 20814707023095 | 51585B | Blue Film Gown with Thumb Loop | OEA | Non-Surgical Isolation Gown | Precept® | ||
5 | 20814707022715 | 51586B | Blue Film Gown with Thumb Loop | OEA | Non-Surgical Isolation Gown | Precept® | ||
6 | 20814707022654 | 5030 | Chemotherapy Gown with Knit Cuffs | OEA | Non-Surgical Isolation Gown | Precept® | ||
7 | 20814707022364 | 51606 | Isolation Gown | OEA | Non-Surgical Isolation Gown | Precept® | ||
8 | 20814707022227 | 8576B | Blue Film Gown | OEA | Non-Surgical Isolation Gown | Precept® | ||
9 | 20814707022210 | 8572B | Blue Film Gown | OEA | Non-Surgical Isolation Gown | Precept® | ||
10 | 20814707022104 | 42138 | Shoe Cover - Non-Conductive | FXP | Cover, Shoe, Operating-Room | Precept® | ||
11 | 20814707022098 | 42137 | Safe-T-Tread Shoe Cover - Non-Conductive | FXP | Cover, Shoe, Operating-Room | Precept® | ||
12 | 20814707022081 | 42135 | Safe-T-Tread Shoe Cover - Non-Conductive | FXP | Cover, Shoe, Operating-Room | Precept® | ||
13 | 20814707022074 | 42134 | Shoe Cover - Non-Conductive | FXP | Cover, Shoe, Operating-Room | Precept® | ||
14 | 20814707022050 | 42131 | Safe-T-Tread Shoe Cover - Non-Conductive | FXP | Cover, Shoe, Operating-Room | Precept® | ||
15 | 20814707021756 | 0456 | 3/4 Sleeve Patient Gown | FME | Gown, Examination | Precept® | ||
16 | 20814707021732 | 51116 | Isolation Gown with Knit Cuffs | OEA | Non-Surgical Isolation Gown | Precept® | ||
17 | 20814707021725 | 51113 | Isolation Gown with Knit Cuffs | OEA | Non-Surgical Isolation Gown | Precept® | ||
18 | 20814707021718 | 51112 | Isolation Gown with Knit Cuffs | OEA | Non-Surgical Isolation Gown | Precept® | ||
19 | 20814707021701 | 51108 | Isolation Gown with Elastic Cuffs | OEA | Non-Surgical Isolation Gown | Precept® | ||
20 | 20814707021695 | 42671 | Bootcovers | FXP | Cover, Shoe, Operating-Room | Precept® | ||
21 | 20814707021688 | 42571 | Bootcovers | FXP | Cover, Shoe, Operating-Room | Precept® | ||
22 | 20814707021480 | 5560 | Isolation Gown with Elastic Cuffs | OEA | Non-Surgical Isolation Gown | Precept® | ||
23 | 20814707021473 | 5558 | Patient Robe | FME | Gown, Examination | Precept® | ||
24 | 20814707021466 | 5040 | Cover Gown with Open Back | OEA | Non-Surgical Isolation Gown | Precept® | ||
25 | 20814707021459 | 2526 | Protective Sleeves | LYU | Accessory, Surgical Apparel | Precept® | ||
26 | 20814707021442 | 0449 | Patient Gown with Attached Belt | FME | Gown, Examination | Precept® | ||
27 | 20814707021435 | 0448 | Patient Gown with Detached Belt | FME | Gown, Examination | Precept® | ||
28 | 20814707021428 | 0447 | Patient Gown with Attached Belt | FME | Gown, Examination | Precept® | ||
29 | 20814707021411 | 0446 | Patient Gown with Detached Belt | FME | Gown, Examination | Precept® | ||
30 | 20814707021404 | 0445 | Patient Gown with Detached Belt | FME | Gown, Examination | Precept® | ||
31 | 20814707021398 | 0444 | Patient Gown with Detached Belt | FME | Gown, Examination | Precept® | ||
32 | 20814707021381 | 0443 | Patient Gown - No Belt | FME | Gown, Examination | Precept® | ||
33 | 20814707021374 | 0442 | Patient Gown - No Belt | FME | Gown, Examination | Precept® | ||
34 | 20814707021367 | 0441 | Patient Gown | FME | Gown, Examination | Precept® | ||
35 | 20814707021350 | 0440 | Patient Gown | FME | Gown, Examination | Precept® | ||
36 | 20814707021343 | 0110 | Isolation Gown with Knit Cuffs | OEA | Non-Surgical Isolation Gown | Precept® | ||
37 | 20814707021336 | 0109 | Isolation Gown with Knit Cuffs | OEA | Non-Surgical Isolation Gown | Precept® | ||
38 | 20814707021091 | 0455 | Exam Cape | FME | Gown, Examination | Precept® | ||
39 | 20814707021084 | 35 2502 | Protective Sleeve | LYU | Accessory, Surgical Apparel | Precept® | ||
40 | 20814707021077 | 8571 | Cysto Apron | LYU | Accessory, Surgical Apparel | Precept® | ||
41 | 20814707021053 | 5246 | Legionnaire Surgical Hood with Tape Tab Closure | FYF | Cap, Surgical | Precept® | ||
42 | 20814707021022 | 35 60260L | Full-face Pullover Cleanroom Hood with Ties | FYF | Cap, Surgical | Precept® | ||
43 | 20814707021015 | 35 60230L | Full-face Cleanroom Hood with Snap Closure | FYF | Cap, Surgical | Precept® | ||
44 | 20814707020971 | 4223 | Nonwoven Shoe Covers | FXP | Cover, Shoe, Operating-Room | Precept® | ||
45 | 20814707020964 | 35 60510XL | 20" Cleanroom Boot Covers with Embossed Poly Sole | FXP | Cover, Shoe, Operating-Room | Precept® | ||
46 | 20814707020957 | 35 60510L | 20" Cleanroom Boot Covers with Embossed Poly Sole | FXP | Cover, Shoe, Operating-Room | Precept® | ||
47 | 20814707020940 | 35 60420XL | Cleanroom Shoe Covers with Embossed Poly Sole | FXP | Cover, Shoe, Operating-Room | Precept® | ||
48 | 20814707020933 | 35 60420L | Cleanroom Shoe Covers with Embossed Poly Sole | FXP | Cover, Shoe, Operating-Room | Precept® | ||
49 | 20814707020841 | 51193B | Over-the-Head Thumb Loop Gown with Elastic Wrists - Open Back | OEA | Non-Surgical Isolation Gown | Precept® | ||
50 | 20814707020810 | 51192B | Over-the-Head Thumb Loop Gown with Elastic Wrists - Open Back | OEA | Non-Surgical Isolation Gown | Precept® |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08056646501441 | 30.M1221.00 | 3-LAYER FACE MASK WITH SPLASHGUARD VISOR AND ELASTIC BANDS - LIGHT BLUE | FACE MASKS | OMNIA SRL | |
2 | 08056646501427 | 30.M1309.00 | 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - PURPLE | FACE MASKS | OMNIA SRL | |
3 | 08056646501403 | 30.M1308.00 | 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - ORANGE | FACE MASKS | OMNIA SRL | |
4 | 08056646501380 | 30.M1307.00 | 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - WITH PRINTING | FACE MASKS | OMNIA SRL | |
5 | 08056646501366 | 30.M1305.00 | 3-LAYER FACE MASK WITH STRINGS - LIGHT GREEN | FACE MASKS | OMNIA SRL | |
6 | 08056646501342 | 30.M1303.00 | 3-LAYER FACE MASK WITH STRINGS - LIGHT BLUE | FACE MASKS | OMNIA SRL | |
7 | 08056646501328 | 30.M1302.00 | 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - BLUE | FACE MASKS | OMNIA SRL | |
8 | 08056646501298 | 30.M1301.00 | 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - GREEN | FACE MASKS | OMNIA SRL | |
9 | 08056646503216 | 30.M1304.00 | 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - YELLOW | FACE MASKS | OMNIA SRL | |
10 | 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 | |
11 | 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 | |
12 | H816PFLEL81 | PFLEL8 | PFLEL8-1 | High-Efficiency Face Mask w/ Earloop | Shield | CERTOL INTERNATIONAL, LLC |
13 | H816PFL0081 | PFL008 | PFL008-1 | High-Efficiency Face Mask with Headband | Shield | CERTOL INTERNATIONAL, LLC |
14 | H66810186101 | 1018610 | 1018610 | Optima Ear Loop Procedural Masks Pink | Prehma | KEYSTONE INDUSTRIES |
15 | H66810185101 | 1018510 | 1018510 | Surgical Tie-On Masks Blue | Prehma | KEYSTONE INDUSTRIES |
16 | H66810184101 | 1018410 | 1018410 | Optima Ear Loop Procedural Masks Green | Prehma | KEYSTONE INDUSTRIES |
17 | H66810182101 | 1018210 | 1018210 | Procedural Ear Loop Masks Green | Prehma | KEYSTONE INDUSTRIES |
18 | H66810180101 | 1018010 | 1018010 | Procedural Ear Loop Masks Blue | Prehma | KEYSTONE INDUSTRIES |
19 | H66810171101 | 1017110 | 1017110 | Surgical Cone Masks Pink | Prehma | KEYSTONE INDUSTRIES |
20 | H66810170101 | 1017010 | 1017010 | Surgical Cone Masks Blue | Prehma | KEYSTONE INDUSTRIES |
21 | 07613154174447 | 0400668000 | 0400668000 | Low Profile Short Lens-Non Sterile | NA | STRYKER CORPORATION |
22 | 07613154174430 | 0400667000 | 0400667000 | Low Profile Short Lens-Sterile | NA | STRYKER CORPORATION |
23 | 07613154174423 | 0400666000 | 0400666000 | Low Profile Wrap Around Lens - Non-Sterile | NA | STRYKER CORPORATION |
24 | 07613154174416 | 0400665000 | 0400665000 | Low Profile Wrap Around Lens-Sterile | NA | STRYKER CORPORATION |
25 | 07613154128389 | 0400663000 | 0400663000 | Short Lens-Sterile | NA | STRYKER CORPORATION |
26 | 07613154128372 | 0400661000 | 0400661000 | Wrap Around Lens-Sterlie | NA | STRYKER CORPORATION |
27 | 07613154096671 | 0400664000 | 0400664000 | Short Lens - Non-Sterile | NA | STRYKER CORPORATION |
28 | 07613154096664 | 0400662000 | 0400662000 | Wrap Around Lens - Non-Sterile | NA | STRYKER CORPORATION |
29 | 07613154096657 | 0400660000 | 0400-660-000 | Face Guard Headgear | SteriShield | STRYKER CORPORATION |
30 | 07332430084798 | 4235-00 | 4235 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
31 | 07323190046065 | 42291-01 | 42291 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
32 | 07323190046003 | 42281-01 | 42281 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
33 | 07323190045945 | 4225-01 | 4225 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
34 | 07323190045914 | 42241-01 | 42241 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
35 | 07323190045198 | 42371-02 | 42371 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
36 | 07323190045167 | 42331-02 | 42331 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
37 | 07323190043347 | 42671-01 | 42671 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
38 | 07323190043286 | 42321-01 | 42321 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
39 | 07323190001125 | 42391-02 | 42391 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
40 | 07323190000920 | 42381-01 | 42381 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
41 | 07323190000777 | 42341-01 | 42341 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
42 | 07323190000654 | 42311-01 | 42311 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
43 | 07323190000593 | 42301-01 | 42301 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
44 | 07323190000531 | 42361-01 | 42361 | Barrier | MÖLNLYCKE HEALTH CARE AB | |
45 | 06973163400007 | 1 | KINGFA | GUANGDONG KINGFA SCI.&TECH. CO., LTD. | ||
46 | 06974960067103 | M1710 | Disposable Medical Face Mask Level 2, Ear-loop, 17.5*9.5cm | S&J | XIANTAO S&J PROTECTIVE PRODUCTS CO., LTD | |
47 | 06974960062238 | M2223 | Disposable Medical Face Mask Level 2 (Non-Sterile) | S&J | XIANTAO S&J PROTECTIVE PRODUCTS CO., LTD | |
48 | 06974960061132 | M2213 | S&J | XIANTAO S&J PROTECTIVE PRODUCTS CO., LTD | ||
49 | 06973824915680 | ZKM-U01 | Medical Surgical Mask is intended to be worn to protect both patients and health Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. This is a single use device, provided non-sterile. | ZhengKang | GUANGZHOU ZHENGKANG MEDICAL EQUIPMENT CO., LTD. | |
50 | 06973675392562 | 5R-DM | Medical Face Mask | 5R MED | 5R MED INSTRUMENTS (CHENGDU) CO., LTD |