Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Laparoscopic tissue manipulation forceps/working-channel FDA UDI
- Device Name
- Mixter dissecting forceps, non-rotatable, double-action, 5.0mm diameter, 450.0mm working length, fine, angled 90 degrees tips, fine serrated jaws, outer sheath, carbon fiber ring handle, HF connection FDA UDI
- Model / Reference
- Mixter dissecting forceps FDA UDI
- Description
- Mixter dissecting forceps, non-rotatable, double-action, 5.0mm diameter, 450.0mm working length, fine, angled 90 degrees tips, fine serrated jaws, outer sheath, carbon fiber ring handle, HF connection FDA UDI
Identifiers
- Catalog Number
- 97-256 FDA UDI
- Primary DI / UDI-DI
- 00190660066277 FDA UDI
- FDA Product Code
- GEN FDA UDI
- GMDN Term
- Laparoscopic tissue manipulation forceps/working-channel 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: Laparoscopic tissue manipulation forceps/working-channel
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Laparoscopic tissue manipulation forceps/working-channel.
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- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
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 2b328e05-c809-4c5b-99ca-f5e7b9c571b9 35 fields · synced May 30, 2026