AccessGUDID - DEVICE: Viscera Retainer Radiopaque Center Spine (00857180007219)

GUDID

Device Identifier (DI) Information

Brand Name: Viscera Retainer Radiopaque Center Spine
Version or Model: Small
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RMD3202
Company Name: RAINBOW MEDICAL DEVICES LLC

Primary DI Number: 00857180007219
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116723413 *Terms of Use

Device Description: One unit packaged in a Poly/Poly Chevron sealed pouch, Gama Sterilized with a 3 year shelf life. The Viscera Retainer is made up of green plastic and is flat on one side with ribs on the other to support placement in viscera region with a over molded radiopaque center spine up the middle of the unit for additional support for placement and extraction with an attached pull cord and ring for easy removal when suturing is about complete.

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":	Yes
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?
13371	Viscera retention paddle	A sterile, hand-held, flat device designed to be temporarily placed within a body cavity to retain and protect organs (i.e., viscera) while the surgeon performs a suturing procedure (typically internal wound closure). It is in the form of a thin, flexible, synthetic polymer paddle that may have an attached cord that remains outside the body to assist in device removal prior to external wound closure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCZ	Retainer, Surgical

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: 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
Width: 5.6 Inch
Height: 8.5 Inch

Device Record Status

Public Device Record Key: 997cd697-c6b9-4acb-8cf9-d13432286b77
Public Version Date: February 15, 2019
Public Version Number: 1
DI Record Publish Date: January 15, 2019