AccessGUDID - DEVICE: Divergence® Anterior Cervical Fusion System (00643169362277)

GUDID

Device Identifier (DI) Information

Brand Name: Divergence® Anterior Cervical Fusion System
Version or Model: 66202690
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00643169362277
Issuing Agency: GS1
Commercial Distribution End Date: September 26, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: TRIAL 66202690 NP PARALLEL 9-10X20X16

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?
44788	Spinal implant trial	A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OVE	Intervertebral fusion device with integrated fixation, cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141599	000

Device Exempt from Premarket Submission: No 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
Angle: 0.0 degree
Device Size Text, specify: H=9-10MM
Depth: 16.0 Millimeter
Width: 20.0 Millimeter

Device Record Status

Public Device Record Key: 92c90c66-daef-48f0-9499-fb9abf0fa1de
Public Version Date: October 13, 2022
Public Version Number: 5
DI Record Publish Date: July 04, 2016