Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Spinal rongeur FDA UDI
- Device Name
- Kerrison swivel take-a-part rongeur, working length 200mm, thin footplate, angled down 40 degrees, 2.0mm bite, small handle FDA UDI
- Model / Reference
- Kerrison swivel take-a-part rongeur FDA UDI
- Description
- Kerrison swivel take-a-part rongeur, working length 200mm, thin footplate, angled down 40 degrees, 2.0mm bite, small handle FDA UDI
Identifiers
- Catalog Number
- 99-231 FDA UDI
- Primary DI / UDI-DI
- 00190660150853 FDA UDI
- FDA Product Code
- LRY FDA UDI
- GMDN Term
- Spinal rongeur 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: Spinal rongeur
Discover the Ambler Surgical Kerrison swivel take-a-part rongeur, a durable and versatile surgical instrument designed for cutting through tough tissues during open spinal surgery. With its sharp, scoop-shaped jaws and reusable design, this device is perfect for surgeons looking to improve their performance.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Ambler Surgical, LLC
Sources (1)
- FDA UDI ecf1c3e1-ba91-4f09-957c-9fa6ba606fdd 35 fields · synced Jul 29, 2026