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Wire Pass Drill

FDA UDI

Class II (US FDA UDI)

by Acra-Cut Inc

Identity

Trade Name
Wire Pass Drill FDA UDI
Generic Name
Cranial trephine, single-use FDA UDI
Device Name
Wire Pass Drill 800-330 Single FDA UDI
Model / Reference
800-330 Single FDA UDI
Description
Wire Pass Drill 800-330 Single FDA UDI

Identifiers

Catalog Number
800-330 Single FDA UDI
Primary DI / UDI-DI
00810607000422 FDA UDI
510(k) Number
K911812 FDA UDI
FDA Product Code
HBE FDA UDI
GMDN Term
Cranial trephine, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4310 FDA UDI
Commercial Distribution
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

No

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

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Cranial trephine, single-use

Wire Pass Drill by Acra-Cut Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranial trephine, single-use.

Cleared under the same submission

K911812 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acra-Cut Inc

Sources (1)

  • FDA UDI 803ab340-3620-4df3-b35e-0c43146df29c 36 fields · synced Jun 1, 2026