AccessGUDID - DEVICE: Medtronic Reusable Instruments (00673978047768)

GUDID

Device Identifier (DI) Information

Brand Name: Medtronic Reusable Instruments
Version or Model: 825-220
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00673978047768
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: INSTRUMENT 825-220 CABLE CRIMPER

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?
44798	Internal spinal fixation system cable crimp	An implantable device intended to be used as part of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is used to lock implanted spinal fixation cable(s) after the surgeon has appropriately tensioned them. It is made of high-grade stainless steel alloy or medical grade titanium (Ti), and is locked around the cable with a dedicated cable crimper.	Active	true

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: 737d7900-552b-4346-a2ca-9150e7c15a0b
Public Version Date: December 08, 2023
Public Version Number: 2
DI Record Publish Date: November 26, 2022