AccessGUDID - DEVICE: Fisch footplate perforator (04250381849538)

GUDID

Device Identifier (DI) Information

Brand Name: Fisch footplate perforator
Version or Model: 10-658-08
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-658-08
Company Name: Spiggle & Theis Medizintechnik GmbH

Primary DI Number: 04250381849538
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332893028 *Terms of Use

Device Description: 0.8 mm, 16 cm

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":	Yes
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?
11334	Automatic cranial perforator, reusable	A metallic rotary endpiece designed to cut a hole(s) or a circular section(s) of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It is available in various configurations such as: 1) two coaxial drill shafts (one rotating inside the other with the inner drill shaft extending slightly beyond the outer cutter); or 2) a single trepan bur rotating a in protective sleeve, both having a drive shank that connects to a powered handpiece and a built-in clutch mechanism that disengages with penetration of the cutter through the skull. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JYS	PERFORATOR, EAR-LOBE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 9c6cbc70-d6c5-49d6-88db-d30fd0925cc4
Public Version Date: September 21, 2022
Public Version Number: 1
DI Record Publish Date: September 13, 2022