Identity
- Trade Name
- Sklar® FDA UDI
- Generic Name
- Ligation clip, metallic FDA UDI
- Device Name
- LIGATION CLIPS SM 120BX STER FDA UDI
- Model / Reference
- 31-7300 FDA UDI
- Description
- LIGATION CLIPS SM 120BX STER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 40649111341053 FDA UDI
- 510(k) Number
- K111930 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ligation clip, metallic
Sklar® by Sklar Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K111930 also covers:
- EUROPCLIP — Ackermann Instrumente GmbH
- EUROPCLIP — Ackermann Instrumente GmbH
- EUROPCLIP — Ackermann Instrumente GmbH
- EUROPCLIP — Ackermann Instrumente GmbH
- EUROPCLIP — Ackermann Instrumente GmbH
- EUROPCLIP — Ackermann Instrumente GmbH
- Novo Surgical — NOVO SURGICAL, INC.
- Novo Surgical — NOVO SURGICAL, INC.
- Novo Surgical — NOVO SURGICAL, INC.
- Novo Surgical — NOVO SURGICAL, INC.
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
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
- Sklar Corporation
Sources (1)
- FDA UDI 7198fb31-bfb9-4ade-a96e-eda480537d30 34 fields · synced May 30, 2026