Identity
- Trade Name
- Batrik Suture Clmp Tags FDA UDI
- Generic Name
- Suturing needle holder, single-use FDA UDI
- Device Name
- SUTURE CLAMP TAGS NON-STERILE EUDAMED"Suture Clamp Tags, Radio Opaque, Non-Sterile, Yellow, Standard ø 0.06"" x 0.5""L" FDA UDI
- Model / Reference
- 911-1005 EUDAMEDFDA UDI
- Description
- "Suture Clamp Tags, Radio Opaque, Non-Sterile, Yellow, Standard ø 0.06"" x 0.5""L" FDA UDI
Identifiers
- Catalog Number
- 91-1005 FDA UDI
- Primary DI / UDI-DI
- 00690521011045 EUDAMEDFDA UDI
- Basic UDI-DI
- 6905210SCTNS1000BT EUDAMED
- FDA Product Code
- KDC FDA UDI
- EMDN Code
- H900802 SINGLE-USE NEEDLE HOLDERS EUDAMED
- GMDN Term
- Suturing needle holder, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Suture Clamp Tags Non-Sterile 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 | 6905210SCTNS1000BT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Batrik Medical Manufacturing Inc.
- EUDAMED SRN
- CA-MF-000007738
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED f97d86b2-1acc-424d-8355-861a3cd240b1 61 fields · synced Jul 22, 2026
- FDA UDI a12012c0-4e70-493b-aecf-ab7ac430e7fb 36 fields · synced May 27, 2026