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" Micro Kerrison Rongeur, Detachable, 3mm Bite, 40 Degree Up, 9.0mm Opening, Small Handles, Thin Footplate, Black and Gold FDA UDI
Model / Reference: SD922809108 FDA UDI
Description: 8" Micro Kerrison Rongeur, Detachable, 3mm Bite, 40 Degree Up, 9.0mm Opening, Small Handles, Thin Footplate, Black and Gold FDA UDI

Identifiers

Catalog Number: SD922809108 FDA UDI
Primary DI / UDI-DI: B382SD9228091080 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

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

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Also classified as Orthopaedic joint/limb rongeur.

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MICRO FRIEDMAN RONGEUR — SONTEC INSTRUMENTS, INC. · Class I
Sklar® — Sklar Corporation · Class I
PILLING — TELEFLEX INCORPORATED · Class I

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: Surgical Direct, Inc.

Sources (1)

FDA UDI de9823c7-9f77-476c-8fe2-5e77b33207cf 35 fields · synced May 31, 2026