AccessGUDID - DEVICE: Disposable Cranial Perforator (00810607000040)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Cranial Perforator
Version or Model: 200-251 14/11 mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200-251 DGR -II
Company Name: ACRA-CUT INC

Primary DI Number: 00810607000040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 612611459 *Terms of Use

Device Description: Cranial Perforator

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46272	Cranial trephine, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBF	Drills, Burrs, Trephines & Accessories (Compound, Powered)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K833266	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2d73c755-c7bf-42d8-bfd7-cf08d6645f85
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 01, 2017