Identity
- Trade Name
- Dannik FDA UDI
- Generic Name
- Ligation clip, metallic FDA UDI
- Device Name
- Titanium Ligation Clip, Medium/Large FDA UDI
- Model / Reference
- TCML300 FDA UDI
- Description
- Titanium Ligation Clip, Medium/Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850013527328 FDA UDI
- 510(k) Number
- K192711 FDA UDI
- FDA Product Code
- FZP FDA UDI
- GMDN Term
- Ligation clip, metallic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Category: Ligation clip, metallic
Dannik by Dannik LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192711 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dannik LLC
Sources (1)
- FDA UDI 44fcd352-a917-42cf-b355-b7ff7e06fe62 34 fields · synced Jun 8, 2026