AccessGUDID - DEVICE: AUDERE C CERVICAL IMPLANT 5MM X 0° (00857215007825)

GUDID

Device Identifier (DI) Information

Brand Name: AUDERE C CERVICAL IMPLANT 5MM X 0°
Version or Model: 40050000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40050000
Company Name: MET 1 TECHNOLOGIES, LLC

Primary DI Number: 00857215007825
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080474650 *Terms of Use

Device Description: THE AUDERE C SPINAL INTERVETEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVETEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE INTERVERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.

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:	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?
61958	Ceramic spinal interbody fusion cage	A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of a ceramic material [e.g., silicon nitride] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral Fusion Device With Bone Graft, Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 degree
Height: 5 Millimeter

Device Record Status

Public Device Record Key: 3dc63c36-7e41-4921-97fe-7cc724fdaa6a
Public Version Date: February 24, 2020
Public Version Number: 3
DI Record Publish Date: July 10, 2017