Viscera Retainer Radiopaque Center Spine

Basic Information

• Brand Name: Viscera Retainer Radiopaque Center Spine
• Primary DI: 00857180007714
• Version / Model: X-Large
• Catalog Number: RMD3207
• Company Name: RAINBOW MEDICAL DEVICES LLC
• Labeler DUNS: 116723413
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-15
• Public Version: 1
• Public Version Date: 2019-02-15
• Public Version Status: New
• Public Device Record Key: 8bb1662d-916f-45e8-a856-1a740f535252

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. The retainer has an attached pull cord and ring for easy removal when suturing is about complete.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCZ	Retainer, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00857180007738	GS1	Corrugate Box	150	In Commercial Distribution
Primary	00857180007714	GS1
Package	00857180007721	GS1	Corrugate Box	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	7	Inch
Height	10.5	Inch