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Buxton BioMedical

FDA UDI

Class I (US FDA UDI)

by Buxton Biomedical, Inc.

Identity

Trade Name
Buxton BioMedical FDA UDI
Generic Name
Spinal rongeur FDA UDI
Device Name
Roulette Shaft,200x3,40°,tfp FDA UDI
Model / Reference
853-5236 FDA UDI
Description
Roulette Shaft,200x3,40°,tfp FDA UDI

Identifiers

Catalog Number
853-5236 FDA UDI
Primary DI / UDI-DI
B76885352360 FDA UDI
FDA Product Code
EMH FDA UDI
GMDN Term
Spinal rongeur FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 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

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Spinal rongeur

Buxton BioMedical by Buxton Biomedical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal rongeur.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Buxton Biomedical, Inc.

Sources (1)

  • FDA UDI 66902d3f-ca91-4a10-963b-4684e3ca3317 34 fields · synced Jun 1, 2026