AccessGUDID - DEVICE: Novo Surgical (G58657CC86MM400)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: 57CC8-6MM40
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 57CC8-6MM40
Company Name: NOVO SURGICAL, INC.

Primary DI Number: G58657CC86MM400
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: ceramic cut quick clean kerrison rongeur, 10.0 mm opening, 40 degree up, 6.0 mm bite, 8" (20.0 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":	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?
64337	Bone-coring punch, reusable	A hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTX	RONGEUR

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: d660bb57-1aa1-4739-bd1b-adf9dc16ce7e
Public Version Date: December 26, 2023
Public Version Number: 1
DI Record Publish Date: December 18, 2023