Viscera Retainer Radiopaque Center Spine RMD3207

GUDID 00857180007738

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.

RAINBOW MEDICAL DEVICES LLC

Viscera retention paddle

• Primary Device ID: 00857180007738
• NIH Device Record Key: 8bb1662d-916f-45e8-a856-1a740f535252
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Viscera Retainer Radiopaque Center Spine
• Version Model Number: X-Large
• Catalog Number: RMD3207
• Company DUNS: 116723413
• Company Name: RAINBOW MEDICAL DEVICES LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8474772074
• Email: deanstockwell@sbcglobal.net

Device Dimensions

• Height: 10.5 Inch
• Height: 10.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857180007714 [Primary]
GS1	00857180007721 [Package]; Contains: 00857180007714; Package: Corrugate Box [10 Units]; In Commercial Distribution
GS1	00857180007738 [Package]; Contains: 00857180007714; Package: Corrugate Box [150 Units]; In Commercial Distribution

FDA Product Code

• GCZ: Retainer, Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-15
• Device Publish Date: 2019-01-15

On-Brand Devices [Viscera Retainer Radiopaque Center Spine]

• 00857180007738: One unit packaged in a Poly/Poly Chevron sealed pouch, Gama Sterilized with a 3 year shelf life.
• 00857180007639: One unit packaged in a Poly/Poly Chevron sealed pouch, Gama Sterilized with a 3 year shelf life.
• 00857180007431: One unit packaged in a Poly/Poly Chevron sealed pouch, Gama Sterilized with a 3 year shelf life.
• 00857180007233: One unit packaged in a Poly/Poly Chevron sealed pouch, Gama Sterilized with a 3 year shelf life.