AccessGUDID - DEVICE: ROMEO 2 PAD INSTRUMENTATION (07640151095048)

GUDID

Device Identifier (DI) Information

Brand Name: ROMEO 2 PAD INSTRUMENTATION
Version or Model: PAD-IN 12 00-N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PAD-IN 12 00-N
Company Name: SpineArt SA

Primary DI Number: 07640151095048
Issuing Agency: GS1
Commercial Distribution End Date: February 05, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 483016148 *Terms of Use

Device Description: Spinous process compression forceps

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?
44378	Bone distraction forceps	A hand-held, manual, open-surgery instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWT	Template

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 0a30e403-ddce-4ee7-8088-f34333418d86
Public Version Date: August 21, 2019
Public Version Number: 3
DI Record Publish Date: July 31, 2018