Viscera Retainer Radiopaque Center Spine

FDA UDI

Class I (US FDA UDI)

by Rainbow Medical Devices Llc

Identity

Trade Name: Viscera Retainer Radiopaque Center Spine FDA UDI
Generic Name: Viscera retention paddle FDA UDI
Device Name: 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. FDA UDI
Model / Reference: X-Large FDA UDI
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. FDA UDI

Identifiers

Catalog Number: RMD3207 FDA UDI
Primary DI / UDI-DI: 00857180007714 FDA UDI
FDA Product Code: GCZ FDA UDI
GMDN Term: Viscera retention paddle FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Width — 7 Inch FDA UDI
Height — 10.5 Inch FDA UDI

Category: Viscera retention paddle

Viscera Retainer Radiopaque Center Spine by Rainbow Medical Devices Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Rainbow Medical Devices Llc

Sources (1)

FDA UDI 8bb1662d-916f-45e8-a856-1a740f535252 36 fields · synced May 30, 2026