Identity
- Trade Name
- A.M.I. Knotpusher Premium FDA UDI
- Generic Name
- Suture knot pusher, reusable FDA UDI
- Device Name
- Knot pusher for placing knots for laparoscopic surgery. The various Knotpushers are intended for ligature passing and knot tying. FDA UDI
- Model / Reference
- APK 001 FDA UDI
- Description
- Knot pusher for placing knots for laparoscopic surgery. The various Knotpushers are intended for ligature passing and knot tying. FDA UDI
Identifiers
- Catalog Number
- APK 001 FDA UDI
- Primary DI / UDI-DI
- EAMIAPK0010 FDA UDI
- FDA Product Code
- HCF FDA UDI
- GMDN Term
- Suture knot pusher, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
A.M.I. Knotpusher Premium by AMI Agency for Medical Innovations GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- AMI Agency for Medical Innovations GmbH
Sources (1)
- FDA UDI d7dc14da-3c2b-4d5e-b085-ab9b6fa77ecd 35 fields · synced May 30, 2026