AccessGUDID - DEVICE: KOMET Bur Blocks (E226036291A11)

GUDID

Device Identifier (DI) Information

Brand Name: KOMET Bur Blocks
Version or Model: 9891.000. 2.A1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9891.000. 2
Company Name: Gebr. Brasseler GmbH & Co. KG

Primary DI Number: E226036291A11
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317409001 *Terms of Use

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?
64239	Sterilizer/disinfector rack instrument-holding insert, reusable	A device intended to be fitted into the rack/container/tray of a sterilizer or disinfector to hold, position, and sometimes protect a medical/surgical instrument(s) during a sterilization and/or disinfection procedure. It may be available in various forms including a plug-like cone with a hollow centre for instrument placement. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	TRAY, SURGICAL, INSTRUMENT

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: 9be445e6-04fe-459a-885e-3eef3e718484
Public Version Date: February 09, 2023
Public Version Number: 1
DI Record Publish Date: February 01, 2023