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Acra-Cut Reusable Cranial Perforator

FDA UDI

Class II (US FDA UDI)

by Acra-Cut Inc

Identity

Trade Name
Acra-Cut Reusable Cranial Perforator FDA UDI
Generic Name
Cranial trephine, reusable FDA UDI
Device Name
Acra-Cut Reusable Cranial Perforator FDA UDI
Model / Reference
200-171 DGR-O FDA UDI
Description
Acra-Cut Reusable Cranial Perforator FDA UDI

Identifiers

Catalog Number
200-171 DGR-O FDA UDI
Primary DI / UDI-DI
00810607000491 FDA UDI
510(k) Number
K833266 FDA UDI
FDA Product Code
HBF FDA UDI
GMDN Term
Cranial trephine, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4305 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Cranial trephine, reusable

Acra-Cut Reusable Cranial Perforator by Acra-Cut Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranial trephine, reusable.

Cleared under the same submission

K833266 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 e8a80c81-e664-479f-91da-d940d7a6574b 36 fields · synced May 30, 2026