Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Spinal rongeur FDA UDI
- Device Name
- Decker pituitary rongeur, 8", working length 140mm, curved left, 1.5mm x 5.0mm cup jaws, ring handle, titanium FDA UDI
- Model / Reference
- 75-263 FDA UDI
- Description
- Decker pituitary rongeur, 8", working length 140mm, curved left, 1.5mm x 5.0mm cup jaws, ring handle, titanium FDA UDI
Identifiers
- Catalog Number
- 75-263 FDA UDI
- Primary DI / UDI-DI
- 00190660145972 FDA UDI
- 510(k) Number
- K081651 FDA UDI
- FDA Product Code
- HAE FDA UDI
- GMDN Term
- Spinal rongeur FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4840 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
No
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
Ambler Surgical by Ambler Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal rongeur.
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Cleared under the same submission
K081651 also covers:
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI a2f48448-9e68-4a4d-afdc-6777250aa4cf 36 fields · synced Jun 8, 2026