← Back to catalogue

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
Burr, Shannon Recta Larga 2.2mm FDA UDI
Model / Reference
6100.0002 FDA UDI
Description
Burr, Shannon Recta Larga 2.2mm FDA UDI

Identifiers

Catalog Number
6100.0002 FDA UDI
Primary DI / UDI-DI
00810136430035 FDA UDI
510(k) Number
K230945 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bur, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 2.2 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.

Cleared under the same submission

K230945 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Forma Medical, Inc.

Sources (1)

  • FDA UDI 96139f69-4851-4a18-a95a-07fe7f7a641a 37 fields · synced May 30, 2026