AccessGUDID - DEVICE: HYDROLIFT (04046963409203)

GUDID

Device Identifier (DI) Information

Brand Name: HYDROLIFT
Version or Model: SV004T
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SV004T
Company Name: Aesculap AG

Primary DI Number: 04046963409203
Issuing Agency: GS1
Commercial Distribution End Date: March 14, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: HYDROLIFT VBR SZ.2 (23-28MM)/ENDPLATE S

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Height : 23.000 - 28.000 MM

Device Record Status

Public Device Record Key: c686d98c-383d-457a-a753-c8235281548f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2015