AccessGUDID - DEVICE: Medtronic Reusable Instruments (00673978145372)

GUDID

Device Identifier (DI) Information

Brand Name: Medtronic Reusable Instruments
Version or Model: X0797-035
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00673978145372
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: PROV CRIMP W/ MOD THUMB LEVER

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?
44799	Internal spinal fixation system cable crimper	A scissors-like, heavy-duty, hand-held manual surgical instrument specifically designed to compress (pinch) fixation crimps that are applied to spinal fixation cable(s). The device is used in conjunction with a cable tensioner to lock into final position the cables used to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically designed to be operated by a surgeon with the cable(s) in situ. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXQ	CRIMPER, PIN

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: e2096281-d42b-4b12-a1f1-4138ae89e3f8
Public Version Date: October 17, 2022
Public Version Number: 1
DI Record Publish Date: October 07, 2022