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Surgitube®
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref TP-1100Model Sterile Wound Closure Strips
Identity
- Trade Name
- Suture Strip Plus EUDAMEDSurgitube® FDA UDI
- Generic Name
- Stockinette FDA UDI
- Device Name
- 7/8 in X 5 yd Tubular Gauze, Flesh FDA UDI
- Model / Reference
- Sterile Wound Closure Strips EUDAMEDTP-1100 EUDAMED205F FDA UDI
- Description
- 7/8 in X 5 yd Tubular Gauze, Flesh FDA UDI
Identifiers
- Catalog Number
- GL-205F FDA UDI
- Primary DI / UDI-DI
- 00809958001059 EUDAMEDFDA UDI
- Basic UDI-DI
- 0809958MDRTD0058Q EUDAMED
- Direct Marketing DI
- 00809958001059 EUDAMED
- FDA Product Code
- FQM FDA UDI
- EMDN Code
- H90020199 SUTURE TAPES - OTHER EUDAMED
- GMDN Term
- Stockinette FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5075 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
Yes
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: Stockinette
Surgitube® by Derma Sciences Canada, Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Stockinette.
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Bioseal Inc. — BIOSEAL · Class II
- Bioseal Inc. — BIOSEAL · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- PERFORMANCE HEALTH — Asp Global, LLC · Class I
- Tex-Care Medical — Flynt/Amtex, Inc. · Class I
- Tex-Care Medical — Flynt/Amtex, Inc. · 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 ecf7179a-2952-42bd-9b9c-981ec0ba0dbe 36 fields · synced Jun 19, 2026
- EUDAMED b2493b92-e1bd-44b1-a87f-6d5b85356a13 61 fields · synced Jun 19, 2026