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Surgical Direct

FDA UDI

Class I (US FDA UDI)

by Surgical Direct, Inc.

Identity

Trade Name
Surgical Direct FDA UDI
Generic Name
Orthopaedic joint/limb rongeur FDA UDI
Device Name
8 inch Kerrison Rongeur, 2mm, 40 Degree Up Bite, Super Coat, Thin Footplate FDA UDI
Model / Reference
SD922805142 FDA UDI
Description
8 inch Kerrison Rongeur, 2mm, 40 Degree Up Bite, Super Coat, Thin Footplate FDA UDI

Identifiers

Catalog Number
SD922805142 FDA UDI
Primary DI / UDI-DI
B382SD9228051420 FDA UDI
FDA Product Code
HTX FDA UDI
GMDN Term
Orthopaedic joint/limb 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
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic joint/limb rongeur

Surgical Direct by Surgical Direct, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic joint/limb rongeur.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgical Direct, Inc.

Sources (1)

  • FDA UDI 6562cd42-71ba-4904-8e01-8cb4d7b6f9b7 35 fields · synced May 30, 2026