FDA.report

CONVERTORS

Primary DI
50630140028906
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
4060
Catalog number
4060
Device description
Convertors Brand Bio-Shield Regular Sterilization Wrap
Published
2016-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FRGWrap, sterilization

Product Code Classifications

CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50630140028906PrimaryGS10
10630140028908Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5063014002890650630140028906
1063014002890810630140028908

GMDN Terms

TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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