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Cranitomy Kit Disposable Low Speed

FDA UDI

by Acra-Cut Inc

Identity

Trade Name
Cranitomy Kit Disposable Low Speed FDA UDI
Generic Name
Neurosurgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Cranitomy Kit Consisting of Qty 1 - DI810607000095 Cranial Perforator Catalog# 200-283, QTY 1 - DI 810607000408 Cranial Blade Catalog# 800-140 & QTY 1 -DI 810607000422 Wire Pass Drill Catalog# 800-330. FDA UDI
Model / Reference
400-283 FDA UDI
Description
Cranitomy Kit Consisting of Qty 1 - DI810607000095 Cranial Perforator Catalog# 200-283, QTY 1 - DI 810607000408 Cranial Blade Catalog# 800-140 & QTY 1 -DI 810607000422 Wire Pass Drill Catalog# 800-330. FDA UDI

Identifiers

Catalog Number
400-283 FDA UDI
Primary DI / UDI-DI
00810607000378 FDA UDI
GMDN Term
Neurosurgical procedure kit, non-medicated, single-use FDA UDI

Classification

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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Neurosurgical procedure kit, non-medicated, single-use

Cranitomy Kit Disposable Low Speed by Acra-Cut Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Neurosurgical procedure kit, non-medicated, single-use.

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 9b2c592f-0244-4a73-b22d-77d6e4db6096 35 fields · synced May 30, 2026