Identity
- Trade Name
- ACRA-CUT FDA UDI
- Generic Name
- Automatic cranial perforator, single-use FDA UDI
- Device Name
- Disposable Cranial Perforator FDA UDI
- Model / Reference
- 13/9mm DGR-II FDA UDI
- Description
- Disposable Cranial Perforator FDA UDI
Identifiers
- Catalog Number
- 200-255 FDA UDI
- Primary DI / UDI-DI
- 00810607002556 FDA UDI
- FDA Product Code
- HBF FDA UDI
- GMDN Term
- Automatic cranial perforator, single-use 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
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
Yes
FDA UDI
Category: Automatic cranial perforator, single-use
Acra-Cut by Acra-Cut Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automatic cranial perforator, single-use.
- PHASOR — Phasor Health, LLC · Class II
- EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm — Micromar Indústria e Comércio Ltda · Class II
- EasyDrill Cranial Perforator Ø9 x Ø6 x 3mm — Micromar Indústria e Comércio Ltda · Class II
- Evonos — Evonos GmbH & Co. KG · Class II
- Evonos — Evonos GmbH & Co. KG · Class II
- Zyphr — Stryker Corp. · Class II
- EasyDrill Cranial Perforator Ø14 x Ø11 x 1, 5mm — Micromar Indústria e Comércio Ltda · Class II
- PHASOR — Phasor Health, LLC · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Acra-Cut Inc
Sources (1)
- FDA UDI 1661ffa6-4afb-4709-9217-013a517834e4 34 fields · synced May 30, 2026