FDA.reportPublic FDA data

Viscera Retainer Radiopaque Center Spine

Primary DI
00857180007738
Brand
Viscera Retainer Radiopaque Center Spine
Company
RAINBOW MEDICAL DEVICES LLC
Model
X-Large
Catalog number
RMD3207
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.
Published
2019-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCZRetainer, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCZRetainer, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857180007721PackageGS110In Commercial Distribution
00857180007738PackageGS1150In Commercial Distribution
00857180007714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857180007721008571800077218571800077210857180007721
00857180007738008571800077388571800077380857180007738
00857180007714008571800077148571800077140857180007714

GMDN Terms#

Term, Definition table
TermDefinition
Viscera retention paddleA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height10.5Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8474772074deanstockwell@sbcglobal.net

Regulatory Flags#

DUNS number
116723413
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857180007219Viscera Retainer Radiopaque Center SpineSmallRMD32022019-01-15
00857180007417Viscera Retainer Radiopaque Center SpineMediumRMD32042019-01-15
00857180007615Viscera Retainer Radiopaque Center SpineLargeRMD32062019-01-15
00857180007714Viscera Retainer Radiopaque Center SpineX-LargeRMD32072019-01-15
00857180007233Viscera Retainer Radiopaque Center SpineSmallRMD32022019-01-15
00857180007431Viscera Retainer Radiopaque Center SpineMediumRMD32042019-01-15
00857180007639Viscera Retainer Radiopaque Center SpineLargeRMD32062019-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511123086Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123093Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123109Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123116Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123123Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123130Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00843511123147Omnia Medical TiBrid™- A/SA OMNIA MEDICAL, LLCGCZ2023-10-18
00613244000011Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
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00613244000035Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000042Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000066Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
00613244000004Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400001100Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
61324400002800Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
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61324400006600Viscera Retainer, FishADEPT MED INTERNATIONAL INCGCZ2023-02-16
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00816101010363Cross Element Guide RetainerTOBY ORTHOPAEDICSGCZ2020-08-28
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