AccessGUDID - DEVICE: GSO GS1 Spacer (M9935023080)

GUDID

Device Identifier (DI) Information

Brand Name: GSO GS1 Spacer
Version or Model: 502308
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: UNIFIED SPINE, LLC

Primary DI Number: M9935023080
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118413370 *Terms of Use

Device Description: Spacerhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=71318#

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?
63917	Orthopaedic bone fixation plate spacer	A small, non-sterile, threaded implantable device intended to be used to maintain a space between an orthopaedic bone fixation plate and the bone to which the plate is fixed, to reduce complications of impaired blood flow in the periosteum. It is made of metal and is screwed into an empty screw hole, producing a short projection on the inside of the plate.	Active	true

FDA Product Code

[?]

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: 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: 8 Millimeter

Device Record Status

Public Device Record Key: 59056a7e-dcaa-42ca-8a34-0a6db86aed08
Public Version Date: July 01, 2024
Public Version Number: 6
DI Record Publish Date: July 08, 2016