AccessGUDID - DEVICE: Centurion (10653160274797)

GUDID

Device Identifier (DI) Information

Brand Name: Centurion
Version or Model: BUDBURST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BUDBURST
Company Name: CENTURION MEDICAL PRODUCTS CORPORATION

Primary DI Number: 10653160274797
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017246562 *Terms of Use

Device Description: ST BUR/SM BUD SHAPE/FINE GRIT(BUDBUR)

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:	Yes
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?
46392	General/plastic surgery bur	A small rotary shaft of hard metal (e.g., steel) with fluting or cutting planes of various shapes on one end, designed to excavate soft tissue or cartilage during general and/or plastic surgery. It is usually power-driven by a rotary handpiece or other powered device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GFF	BUR, SURGICAL, GENERAL & PLASTIC SURGERY

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: faec7fb5-c07a-42a0-b95b-30800b509871
Public Version Date: January 10, 2022
Public Version Number: 1
DI Record Publish Date: January 01, 2022