Vertebris

FDA UDI

Class I (US FDA UDI)

by Richard Wolf GmbH

Identity

Trade Name: VERTEBRIS FDA UDI
Generic Name: Orthopaedic bur, reusable FDA UDI
Device Name: BURR ROUND Ø 4MM color code royal blue, PACK=1 PC, WL 350mm, without protection, for use with motor handpieces M5/0 and M5/3, for extraction of bony structures, in endoscopic spine surgery, reusable FDA UDI
Model / Reference: 899751304 FDA UDI
Description: BURR ROUND Ø 4MM color code royal blue, PACK=1 PC, WL 350mm, without protection, for use with motor handpieces M5/0 and M5/3, for extraction of bony structures, in endoscopic spine surgery, reusable FDA UDI

Identifiers

Catalog Number: 899751304 FDA UDI
Primary DI / UDI-DI: 04055207047392 FDA UDI
FDA Product Code: HWE FDA UDI
GMDN Term: Orthopaedic bur, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 4 Millimeter FDA UDI

Category: Orthopaedic bur, reusable

Vertebris by Richard Wolf GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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: Richard Wolf GmbH

Sources (1)

FDA UDI 9bbcc62c-a2b9-475f-9bea-6f81ce85e07a 36 fields · synced May 31, 2026