Identity
- Trade Name
- Amsel Occluder Device FDA UDI
- Generic Name
- Ligation clip, metallic FDA UDI
- Device Name
- The Amsel Occluder Device is designed to easily and securely close blood vessels (veins or arteries as well as hollow ducts) during surgical procedures. It is intended for use in open general surgery procedures on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter. FDA UDI
- Model / Reference
- 100-200 FDA UDI
- Description
- The Amsel Occluder Device is designed to easily and securely close blood vessels (veins or arteries as well as hollow ducts) during surgical procedures. It is intended for use in open general surgery procedures on tubular structures or blood vessels (arteries and veins) wherever a metal ligating clip is indicated and within the size range of 2.0mm to 7.0mm diameter. FDA UDI
Identifiers
- Catalog Number
- 100-200 FDA UDI
- Primary DI / UDI-DI
- 00857774006000 FDA UDI
- 510(k) Number
- K140932 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
No
FDA UDI
MR Conditional FDA UDI
Category: Ligation clip, metallic
Amsel Occluder Device by Amsel Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Amsel Medical
Sources (1)
- FDA UDI 417e7f0c-8fb7-46a6-851a-9f010ab26196 36 fields · synced Jun 8, 2026