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Gazetex®
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref TP-1101Model Sterile Wound Closure Strips
Identity
- Trade Name
- Suture Strip Plus EUDAMEDGazetex® FDA UDI
- Generic Name
- Cotton wool roll FDA UDI
- Device Name
- 6 in X 6 in, 6-ply, "Krinkle" type sponge. Non-Sterile. Bulk FDA UDI
- Model / Reference
- Sterile Wound Closure Strips EUDAMEDTP-1101 EUDAMED9334 FDA UDI
- Description
- 6 in X 6 in, 6-ply, "Krinkle" type sponge. Non-Sterile. Bulk FDA UDI
Identifiers
- Catalog Number
- DUP9334 FDA UDI
- Primary DI / UDI-DI
- 00809958000359 EUDAMEDFDA UDI
- Basic UDI-DI
- 0809958MDRTD0058Q EUDAMED
- Direct Marketing DI
- 00809958000359 EUDAMED
- FDA Product Code
- NAB FDA UDI
- EMDN Code
- H90020199 SUTURE TAPES - OTHER EUDAMED
- GMDN Term
- Cotton wool roll FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4014 FDA UDI
- Market of Registration
- Netherlands 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: Cotton wool roll
Gazetex® by Derma Sciences Canada, Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cotton wool roll.
- Cotton Roll — Dynarex Corp. · Class I
- RHINO RESCUE — Wuxi Emsrun Technology Co., Ltd. · Class I
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories · Class II
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories · Class II
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- RHINO RESCUE — Wuxi Emsrun Technology Co., Ltd. · Class I
- Safco cotton rolls — Safco Dental Supply · 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 585d55b8-c7a6-48ee-94cf-6aa469ff7c29 36 fields · synced Jun 18, 2026
- EUDAMED 187da0b2-bc9d-422b-9136-6dfee3a806c0 61 fields · synced Jun 18, 2026