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Suture Strip®
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref TS-3104Model Sterile Wound Closure Strips
Identity
- Trade Name
- Suture Strip EUDAMEDSuture Strip® FDA UDI
- Generic Name
- Skin-closure adhesive strip FDA UDI
- Device Name
- Suture strip Wound Closure Strips FDA UDI
- Model / Reference
- TS-3104 EUDAMEDFDA UDISterile Wound Closure Strips EUDAMED
- Description
- Suture strip Wound Closure Strips FDA UDI
Identifiers
- Catalog Number
- DERMA-TS3104 FDA UDI
- Primary DI / UDI-DI
- 00809958002179 EUDAMED10753567331045 FDA UDI
- Basic UDI-DI
- 0809958MDRTD0058Q EUDAMED
- Direct Marketing DI
- 00809958002179 EUDAMED
- FDA Product Code
- FPX FDA UDI
- EMDN Code
- H90020199 SUTURE TAPES - OTHER EUDAMED
- GMDN Term
- Skin-closure adhesive strip FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin-closure adhesive strip
Suture Strip® by Derma Sciences Canada, Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Skin-closure adhesive strip.
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- CURAD — MEDLINE INDUSTRIES, INC. · Class I
- CURAD — MEDLINE INDUSTRIES, 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 59c5deb3-49b2-480a-8920-a57b3f527a25 35 fields · synced Jul 9, 2026
- EUDAMED 3c0c4e88-3831-446c-b926-f04ab8e139b7 61 fields · synced Jul 9, 2026