Quick - Radius Disposable Set

FDA UDI

Class II (US FDA UDI)

by Gm Dos Reis Industria E Comercio Ltda

Identity

Trade Name: Quick - Radius Disposable Set FDA UDI
Generic Name: Surgical screwdriver, single-use FDA UDI
Device Name: Quick - Radius Disposable Set - Instruments FDA UDI
Model / Reference: Quick - Radius Disposable Set - Instruments FDA UDI
Description: Quick - Radius Disposable Set - Instruments FDA UDI

Identifiers

Catalog Number: 358-1010 FDA UDI
Primary DI / UDI-DI: 07899258659794 FDA UDI
510(k) Number: K231684 FDA UDI
FDA Product Code: HRS FDA UDI
HWC FDA UDI
GMDN Term: Surgical screwdriver, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical screwdriver, single-use

Quick - Radius Disposable Set by Gm Dos Reis Industria E Comercio Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical screwdriver, single-use.

MS Removal Tool — OSSTEM IMPLANT Co., Ltd. · Class I
HEX DRIVER 3.0 3.5 — BIOPRO, INC. · Class I
Remover Screw — OSSTEM IMPLANT Co., Ltd. · Class I
Orthodontic Screw Removal Tool — OSSTEM IMPLANT Co., Ltd. · Class I
HammerTech — FUSION ORTHOPEDICS, LLC · Class I
Remover Screw — OSSTEM IMPLANT Co., Ltd. · Class I
CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
SR Tip, Φ1.0mm, L 26mm — BIO CONCEPT Co., Ltd. · Class I

Cleared under the same submission

K231684 also covers:

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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Gm Dos Reis Industria E Comercio Ltda

Sources (1)

FDA UDI 5cf74d66-6622-4310-9575-890950fc91e4 35 fields · synced Jun 6, 2026