AccessGUDID - DEVICE: ROMEO Posterior Osteosynthesis system (07640151091323)

GUDID

Device Identifier (DI) Information

Brand Name: ROMEO Posterior Osteosynthesis system
Version or Model: ELL-R8 15 00-S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SpineArt SA

Primary DI Number: 07640151091323
Issuing Agency: GS1
Commercial Distribution End Date: February 04, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 483016148 *Terms of Use

Device Description: Rod Cobalt Chromium / Prebent

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?
37272	Trans-facet-screw internal spinal fixation system, sterile	A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.	Obsolete	true

FDA Product Code

[?]

Product Code	Product Code Name
MNH	Orthosis, Spondylolisthesis Spinal Fixation
MNI	Orthosis, Spinal Pedicle Fixation

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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 500 Millimeter
Outer Diameter: 5.4 Millimeter

Device Record Status

Public Device Record Key: 788f878d-9706-4360-a5ff-e6417b038876
Public Version Date: March 31, 2025
Public Version Number: 7
DI Record Publish Date: October 21, 2015