AccessGUDID - DEVICE: ROMEO 2 INSTRUMENTATION (07640151088422)

GUDID

Device Identifier (DI) Information

Brand Name: ROMEO 2 INSTRUMENTATION
Version or Model: ELL-IN 00 43-N
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ELL-IN 00 43-N
Company Name: SpineArt SA

Primary DI Number: 07640151088422
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483016148 *Terms of Use

Device Description: TAB BREAKER

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:	No
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?
44805	Orthopaedic implantable-device cutter	A heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNI	Orthosis, Spinal Pedicle Fixation
MNH	Orthosis, Spondylolisthesis Spinal Fixation
KWP	Appliance, Fixation, Spinal Interlaminal

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
No Device Sizes

Device Record Status

Public Device Record Key: 78bbddab-616b-4c57-9c19-3873fbbfe6f6
Public Version Date: March 24, 2025
Public Version Number: 3
DI Record Publish Date: December 20, 2018