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Sbh

FDA UDI

Class I (US FDA UDI)

by SBH Surgical

Identity

Trade Name
SBH FDA UDI
Generic Name
Spinal rongeur FDA UDI
Device Name
CHROMA STYLE KERRISON, BLUE, 8", 10MM BITE, NO EJECTOR, 3MM *FLIP APART* FDA UDI
Model / Reference
Chroma - Blue 3mm FDA UDI
Description
CHROMA STYLE KERRISON, BLUE, 8", 10MM BITE, NO EJECTOR, 3MM *FLIP APART* FDA UDI

Identifiers

Catalog Number
G2W4271-83F FDA UDI
Primary DI / UDI-DI
00850068304233 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Dry Heat Sterilization FDA UDI

Category: Spinal rongeur

Sbh by SBH Surgical — 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
SBH Surgical

Sources (1)

  • FDA UDI 8b6f4846-f8d6-47f7-a31e-862e63665b55 35 fields · synced May 30, 2026