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Derma
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 77043Model Petrolatum Gauze Non-Adhering Dressing and Shur-Conform Oil Emulsion Non-Adhering Dressing
Identity
- Trade Name
- Shur-Conform Oil Emulsion Non-Adhering Dressing EUDAMEDDerma FDA UDI
- Generic Name
- Gauze strip, non-antimicrobial FDA UDI
- Device Name
- 0.50 in X 100 yards, non X-Ray detectable surgical gauze packing, made from 28 X 24 mesh gauze, 4-Ply. FDA UDI
- Model / Reference
- Petrolatum Gauze Non-Adhering Dressing and Shur-Conform Oil Emulsion Non-Adhering Dressing EUDAMED77043 EUDAMED9002X FDA UDI
- Description
- 0.50 in X 100 yards, non X-Ray detectable surgical gauze packing, made from 28 X 24 mesh gauze, 4-Ply. FDA UDI
Identifiers
- Catalog Number
- DUP9002X FDA UDI
- Primary DI / UDI-DI
- 00809958000298 EUDAMEDFDA UDI
- Basic UDI-DI
- 0809958MDRTD0028J EUDAMED
- Direct Marketing DI
- 00809958000298 EUDAMED
- FDA Product Code
- NAB FDA UDI
- EMDN Code
- M02030201 GAUZE IMPREGNATED WITHOUT ANTISEPTIC EUDAMED
- GMDN Term
- Gauze strip, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gauze strip, non-antimicrobial
Derma by Derma Sciences Canada, Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gauze strip, non-antimicrobial.
- Bioseal Inc. — BIOSEAL · Class I
- Bioseal Inc. — BIOSEAL · Class I
- Packing Strip — Dynarex Corp. · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- Bioseal Inc. — BIOSEAL · Class I
- Dermacea — Cardinal Health 200, LLC · Class I
- Bioseal Inc. — BIOSEAL · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Derma Sciences Canada, Inc
Sources (2)
- FDA UDI b9d77f03-2f05-46a0-8bbe-d5cfb35d5937 36 fields · synced Aug 2, 2026
- EUDAMED 7b6e9de7-2f0d-4d62-b33b-5dddcb01eb18 61 fields · synced Aug 2, 2026