Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Suture knot pusher, reusable FDA UDI
- Device Name
- Minimally invasive heart knot pusher, 14'', working length 235.0mm, 5.0mm diameter shaft, angled up, standard jaws, round squeeze handle FDA UDI
- Model / Reference
- Minimally invasive heart knot pusher FDA UDI
- Description
- Minimally invasive heart knot pusher, 14'', working length 235.0mm, 5.0mm diameter shaft, angled up, standard jaws, round squeeze handle FDA UDI
Identifiers
- Catalog Number
- 43-144 FDA UDI
- Primary DI / UDI-DI
- 00190660207946 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
- 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Suture knot pusher, reusable
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suture knot pusher, reusable.
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Hayden Medical — Hayden Medical Inc · Class II
- PASHLEY LARYNGOSCOPE KNOT PUSHER — SONTEC INSTRUMENTS, INC. · Class I
- Closed Knot Pusher — Biomet Orthopedics, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- MICTEC KNOT PUSHER — SONTEC INSTRUMENTS, INC. · Class II
- V. Mueller — STERIS CORPORATION · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 782800e6-268f-4069-a14c-21e63378b0e0 35 fields · synced Jun 8, 2026