Identity
- Trade Name
- Spurling Pitutiary Ronguer 4mm/18cm FDA UDI
- Generic Name
- Spinal rongeur FDA UDI
- Device Name
- A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device. FDA UDI
- Model / Reference
- 08-007-18 FDA UDI
- Description
- A hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- 08-007-18 FDA UDI
- Primary DI / UDI-DI
- G25008007180 FDA UDI
- FDA Product Code
- HTX FDA UDI
- GMDN Term
- Spinal rongeur FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 18 Centimeter FDA UDI
Category: Spinal rongeur
Spurling Pitutiary Ronguer 4mm/18cm by N S Surgical Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal rongeur.
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
- Sklar — Sklar Corporation · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- V. Mueller — STERIS CORPORATION · Class II
- Boss Instruments — Boss Instruments, Ltd. · 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
- N S Surgical Company
Sources (1)
- FDA UDI 041172ae-dadf-4e6a-9253-a513266ce7dc 35 fields · synced Jun 1, 2026