FDA.reportPublic FDA data

Acra-Cut Reusable Cranial Perforator

Primary DI
00810607000460
Brand
Acra-Cut Reusable Cranial Perforator
Company
ACRA-CUT INC
Model
200-141 DGR-I
Catalog number
200-141 DGR-I
Device description
Acra-Cut Reusable Cranial Perforator
Published
2017-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K833266000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K833266000ACRA-CUTAcra Cut, Inc.1983-12-29HBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810607000460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810607000460008106070004608106070004600810607000460

GMDN Terms#

Term, Definition table
TermDefinition
Cranial trephine, reusableA neurosurgical blade used to cut/remove circular sections of the skull vault (calvarium) to provide access to the interior, for the insertion of a catheter, a neuroscope for diagnosis or treatments such as, to alleviate intracranial pressure (ICP), obtain cerebrospinal fluid samples, inject radiopaque dyes. It may be used to make several holes for the removal of a bone flap. It is typically a hollow cylinder with a circular, saw-like serrated working edge and a centre drill for guidance. It is an exchangeable device that may be attached to a manually-rotated handle or to a powered rotary surgical handpiece. This device typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9782632210info@acracut.com

Regulatory Flags#

DUNS number
612611459
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810607000224Distraction Screws Caspar type800-499800-4992017-05-01
00810607000231Distraction Screws Caspar type800-499x800-499x2017-05-01
00810607000248Distraction Screw Caspar type800-500800-5002017-05-01
00810607000255Distraction Screws Caspar type800-500x800-500x2017-05-01
00810607000262Distraction Screws Caspar type800-501800-5012017-05-01
00810607000279Distraction Screws Caspar type800-501x800-501x2017-05-01
00810607000286Distraction Screws Caspar type800-502800-5022017-05-01
00810607000293Distraction Screws Caspar type800-502x800-502x2017-05-01
00810607002006ACRA-CUT14/9mm SDR (SMARTdrill)200-5002016-09-23
00810607002211ACRA-CUT14/11mm CDM210-2212016-09-23
00810607002310ACRA-CUT11/7mm DG-II mini200-3312016-09-23
00810607002419ACRA-CUT14/11mm DGR-I200-2412016-09-23
00810607002433ACRA-CUT11/7mm DR-I mini200-2432016-09-23
00810607002518ACRA-CUT14/11mm DGR-II200-2512017-01-17
00810607002532ACRA-CUT11/7mm DGR-II Mini200-2532016-09-23
00810607002556ACRA-CUT13/9mm DGR-II200-2552017-01-17
00810607002716ACRA-CUT14/11mm DGR-O200-2712016-09-23
00810607002754ACRA-CUT13/9mm DGR-O200-2752016-09-23
00810607002839ACRA-CUT8/5mm DGR-OS mini Stereotactic200-2832016-09-23
00810607000019Disposable Cranial Perforator200-241 14/11mm200-241 DGR-I2017-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05999860261001NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261018NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261025NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261032NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261049NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261056NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261230NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
05999860261247NeuroLineEMD Endoszkóp Műszer Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságHBF2025-09-16
04054462020836Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020850Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020874Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020898Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020911Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020935Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020959Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462020973Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462122981Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462122998Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123001Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123018Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123025Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123032Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123049Evonosevonos GmbH & Co. KGHBF2024-04-25
04054462123056Evonosevonos GmbH & Co. KGHBF2024-04-25
07898959543593EasyDrill Cranial Perforator Ø14 x Ø11 x 3mmMicromar Indústria e Comércio LtdaHBF2023-10-30
07898959543609EasyDrill Cranial Perforator Ø14 x Ø11 x 1,5mmMicromar Indústria e Comércio LtdaHBF2023-10-30
07898959543616EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmMicromar Indústria e Comércio LtdaHBF2023-10-30
07898959543623EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmMicromar Indústria e Comércio LtdaHBF2023-10-30
07898959543555EasyDrill Cranial Perforator Ø9 x Ø6 x 3mmMicromar Indústria e Comércio LtdaHBF2022-12-02
07898959543562EasyDrill Cranial Perforator Ø11 x Ø7 x 3mmMicromar Indústria e Comércio LtdaHBF2022-12-02