AccessGUDID - DEVICE: ATHLET (04047844002384)

GUDID

Device Identifier (DI) Information

Brand Name: ATHLET
Version or Model: Main body 7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AT0730
Company Name: SIGNUS Medizintechnik GmbH

Primary DI Number: 04047844002384
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344203948 *Terms of Use

Device Description: The ATHLET VBR System is a lordotic, modular vertebral body replacement system. Caudal and cranial components are offered in a variety of heights and are assembled to create a device construct. An intermediate component is also available and is used betwenn one caudal and one cranial component. The device construct comprises a central cannula for bone graft and lateral fenestrations for bony in-growth.

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Vertebral body prosthesis, sterile	A sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials.

FDA Product Code

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Product Code	Product Code Name
MQP	Spinal Vertebral Body Replacement Device

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 0 and 35 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 30x14x15mm

Device Record Status

Public Device Record Key: c327d1ef-1c03-4699-927f-6c99a6010cdf
Public Version Date: August 21, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015