AccessGUDID - DEVICE: Cranio Guard 25mm fix (07630055505835)

GUDID

Device Identifier (DI) Information

Brand Name: Cranio Guard 25mm fix
Version or Model: 1600887
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1600887-001
Company Name: Bien-Air Surgery SA

Primary DI Number: 07630055505835
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481597719 *Terms of Use
Previous DI: J00716008870011

Device Description: No description.

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:	No
Prescription Use (Rx):	Yes
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?
42981	Trephining power tool attachment	A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to function as a craniotome when an appropriate cutter is inserted. It is inserted through a pre-drilled bur hole or perforator hole and is used to cut a flap in the bone of the skull vault (calvarium). It includes a small shielding tip at the distal end to prevent the end of the cutter penetrating the dura mater membrane. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBC	Motor, Drill, Electric
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam 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: b7c9db93-6051-4f83-a772-0b7c2aff4076
Public Version Date: February 20, 2023
Public Version Number: 1
DI Record Publish Date: February 10, 2023