Identity
- Trade Name
- Batrik Suture Clamp Tags FDA UDI
- Generic Name
- Vascular booties FDA UDI
- Device Name
- Sterile Suture Clamp Tags EUDAMEDSuture Clamp Tags, Radio Opaque, Sterile, Red, Standard, ø 0.06" x 0.5"L FDA UDI
- Model / Reference
- 11-1085 EUDAMEDFDA UDI
- Description
- Suture Clamp Tags, Radio Opaque, Sterile, Red, Standard, ø 0.06" x 0.5"L FDA UDI
Identifiers
- Catalog Number
- 11-1085 FDA UDI
- Primary DI / UDI-DI
- 00690521014404 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210SCTST1004X EUDAMED
- FDA Product Code
- KDC FDA UDI
- EMDN Code
- H9080 SUTURE ACCESSORIES EUDAMED
- GMDN Term
- Vascular booties FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Malta 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sterile Suture Clamp Tags by Batrik Medical Manufacturing Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6905210SCTST1004X | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED f58bb15f-80ae-4cfa-91cb-57be66227ecc 61 fields · synced Jun 18, 2026
- FDA UDI f511f021-85b9-4f82-a08c-5c6d406c1181 36 fields · synced May 30, 2026