FDA.reportPublic FDA data

Disposable Cranial Perforator

Primary DI
00810607000057
Brand
Disposable Cranial Perforator
Company
ACRA-CUT INC
Model
200-253 11/7 mm
Catalog number
200-253 DGR -II
Device description
Cranial Perforator
Published
2017-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
00810607000057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810607000057008106070000578106070000570810607000057

GMDN Terms#

Term, Definition table
TermDefinition
Cranial trephine, single-useA neurosurgical blade used to cut/remove circular sections of the skull vault (calvarium) to provide access to the interior, e.g., for the insertion of a catheter or 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, typically made of high-grade stainless steel, that is attached to a manually rotated handle or to a powered rotary surgical handpiece. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
9782632210info@acracut.com

Regulatory Flags#

DUNS number
612611459
Device count
1
Lot or batch
true
Expiration date on label
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

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