AccessGUDID - DEVICE: Omnia Medical VBR (00843511100346)

GUDID

Device Identifier (DI) Information

Brand Name: Omnia Medical VBR
Version or Model: 06-2V-1420
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06-2V-1420
Company Name: OMNIA MEDICAL, LLC

Primary DI Number: 00843511100346
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079467378 *Terms of Use

Device Description: Omnia Medical VBR, 14mm X 14.5mm X 2mm Spacer

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?
57806	Vertebral body prosthesis, non-sterile	A non-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. This device must be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MQP	Spinal Vertebral Body Replacement Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172323	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
Height: 2 Millimeter
Depth: 14.5 Millimeter
Width: 14 Millimeter

Device Record Status

Public Device Record Key: 44cc565c-b903-4718-bb91-24313d556ffa
Public Version Date: September 10, 2019
Public Version Number: 4
DI Record Publish Date: February 05, 2018