Universal Neuro 2, Universal Neuro III

FDA UDI

Class I (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name: Universal Neuro 2, Universal Neuro III FDA UDI
Generic Name: Fluted surgical drill bit, single-use FDA UDI
Device Name: DRILL, WL 6MM, STRYKER SHAFT FDA UDI
Model / Reference: 91-12506 FDA UDI
Description: DRILL, WL 6MM, STRYKER SHAFT FDA UDI

Identifiers

Catalog Number: 91-12506 FDA UDI
Primary DI / UDI-DI: 04546540543028 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Fluted surgical drill bit, single-use 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

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

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 6.0 Millimeter FDA UDI
Length — 50.0 Millimeter FDA UDI

Category: Fluted surgical drill bit, single-use

Universal Neuro 2, Universal Neuro III by Stryker Leibinger — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Stryker Leibinger

Sources (1)

FDA UDI aa7b7e88-df7c-4562-a133-45ac34a19cbb 35 fields · synced Jun 8, 2026