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Universal Neuro 2, Universal Neuro 3

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
Universal Neuro 2, Universal Neuro 3 FDA UDI
Generic Name
Fluted surgical drill bit, single-use FDA UDI
Device Name
DRILL, WL 4MM, DENTAL SHAFT FDA UDI
Model / Reference
91-12204 FDA UDI
Description
DRILL, WL 4MM, DENTAL SHAFT FDA UDI

Identifiers

Catalog Number
91-12204 FDA UDI
Primary DI / UDI-DI
04546540543011 FDA UDI
510(k) Number
K070876 FDA UDI
FDA Product Code
HBE FDA UDI
GMDN Term
Fluted surgical drill bit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4310 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 48.0 Millimeter FDA UDI
Length — 4.0 Millimeter FDA UDI

Universal Neuro 2, Universal Neuro 3 by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K070876 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Leibinger

Sources (1)

  • FDA UDI 3444a3e8-0435-4c3c-b3bc-8e7547a78cff 37 fields · synced Jun 1, 2026