AccessGUDID - DEVICE: KOMET Surgical Saw Blade (14053613201862)

GUDID

Device Identifier (DI) Information

Brand Name: KOMET Surgical Saw Blade
Version or Model: KM71277.C62..M0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KM71277.C62.
Company Name: Gebr. Brasseler GmbH & Co. KG

Primary DI Number: 14053613201862
Issuing Agency: GS1
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?
44986	Sternum saw blade, reusable	A flat metal surgical instrument with a serrated edge intended to be attached to a dedicated powered surgical saw for cutting the sternum (the breastbone) during cardiovascular surgery. It is available in various forms (e.g., straight or arc-shaped) and is powered by a rapid reciprocating, oscillating or sagittal motion provided by the saw. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFA	BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: e2f3759c-6b79-4cd0-ad8d-774f48d1b9a8
Public Version Date: October 09, 2023
Public Version Number: 1
DI Record Publish Date: September 29, 2023