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Insignia

FDA UDI

Class I (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name
Insignia FDA UDI
Generic Name
Fluted surgical drill bit, reusable FDA UDI
Device Name
2.3mm Drill Bit, 24mm FDA UDI
Model / Reference
137-2024 FDA UDI
Description
2.3mm Drill Bit, 24mm FDA UDI

Identifiers

Primary DI / UDI-DI
00190376242354 FDA UDI
FDA Product Code
HTW FDA UDI
GMDN Term
Fluted surgical drill bit, 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

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

Category: Fluted surgical drill bit, reusable

Insignia by Alphatec Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fluted surgical drill bit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alphatec Spine, Inc.

Sources (1)

  • FDA UDI 6d4bb8fe-89f5-419c-9610-9a24669bc585 34 fields · synced Jun 8, 2026