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Burr

FDA UDI

Class II (US FDA UDI)

by Forma Medical, Inc.

Identity

Trade Name
Burr FDA UDI
Generic Name
Orthopaedic bur, single-use FDA UDI
Device Name
MIS Doty Burr, 4x13mm, Reverse Wedge FDA UDI
Model / Reference
6102.0006 FDA UDI
Description
MIS Doty Burr, 4x13mm, Reverse Wedge FDA UDI

Identifiers

Catalog Number
6102.0006 FDA UDI
Primary DI / UDI-DI
00810136433159 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
GMDN Term
Orthopaedic bur, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 2 Millimeter FDA UDI

Category: Orthopaedic bur, single-use

Burr by Forma Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bur, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Forma Medical, Inc.

Sources (1)

  • FDA UDI a8f223a2-8506-43ce-b98b-95e5aff726dc 35 fields · synced May 30, 2026