In2Bones

FDA UDI

Class I (US FDA UDI)

by In2Bones, USA

Identity

Trade Name: In2Bones FDA UDI
Generic Name: Orthopaedic bur, reusable FDA UDI
Device Name: K-WIRE, S. TROCAR, SMOOTH, .086 X 3.25", NON-STERILE FDA UDI
Model / Reference: C01 N4021 FDA UDI
Description: K-WIRE, S. TROCAR, SMOOTH, .086 X 3.25", NON-STERILE FDA UDI

Identifiers

Catalog Number: C01 N4021 FDA UDI
Primary DI / UDI-DI: 08101755000030 FDA UDI
FDA Product Code: HXI FDA UDI
GMDN Term: Orthopaedic bur, reusable 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

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bur, reusable

In2Bones by In2Bones, USA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic bur, reusable.

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KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
Uniglide Unicondylar Knee Prosthesis — CORIN LTD · Class II
KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · 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: In2Bones, USA

Sources (1)

FDA UDI c2c9880d-27a3-420b-887d-2ec046fa02c3 35 fields · synced May 29, 2026