restor3d Disposable Instrument

FDA UDI

Class I (US FDA UDI)

by Restor3D

Identity

Trade Name: restor3d Disposable Instrument FDA UDI
Generic Name: Cannulated surgical drill bit, single-use FDA UDI
Device Name: 7.0 mm OD, 3.0 mm ID cannulated drill FDA UDI
Model / Reference: 6203-1001 FDA UDI
Description: 7.0 mm OD, 3.0 mm ID cannulated drill FDA UDI

Identifiers

Primary DI / UDI-DI: 00840097510088 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Cannulated surgical drill bit, single-use 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

Yes

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: Cannulated surgical drill bit, single-use

restor3d Disposable Instrument by Restor3D — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cannulated surgical drill bit, single-use.

MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
Sierra™ — SeaSpine Orthopedics Corporation · Class II
VersiTomic Low Profile Ø11.0 mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
FOREFOOT SOLUTIONS™ — Newdeal Sas · Class I
APEX 3D S Total Ankle Replacement System — Paragon 28 · Class I
Arthrex® — Arthrex, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
MEDLINE — MEDLINE INDUSTRIES, INC. · 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

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

Manufacturer

Manufacturer: Restor3D

Sources (1)

FDA UDI 8d86945d-bab1-4b97-9ac6-4404c71c68be 33 fields · synced May 30, 2026