In2Bones

FDA UDI

Class I (US FDA UDI)

by In2bones

Identity

Trade Name: In2Bones FDA UDI
Generic Name: Fluted surgical drill bit, single-use FDA UDI
Device Name: SHANNON BURR LG15 MM STERILE DIA 4.1 X LENGTH 75 MM FDA UDI
Model / Reference: G01 00992 FDA UDI
Description: SHANNON BURR LG15 MM STERILE DIA 4.1 X LENGTH 75 MM FDA UDI

Identifiers

Catalog Number: G01 00992 FDA UDI
Primary DI / UDI-DI: 03760225713969 FDA UDI
FDA Product Code: GFF FDA UDI
GMDN Term: Fluted surgical drill bit, single-use 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Fluted surgical drill bit, single-use

In2Bones by In2bones — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

LEVEL ONE — KLS-Martin L.P. · Class I
T2 ALPHA — Stryker Corp. · Class I
Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD · Class II
Nobel Biocare® — Nobel Biocare AG · Class I
INSTRUMENT — Howmedica Osteonics Corp. · Class I
MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
EVOS — Smith & Nephew, Inc. · Class I
EBA ONE — Citieffe · Class II

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: In2bones

Sources (1)

FDA UDI b2cb4ab4-6944-400d-8f20-73f9b49af528 35 fields · synced Jun 8, 2026