FDA.report

Devon

Primary DI
20884521077413
Brand
Devon
Company
Cardinal Health, Inc.
Model
31319604
Catalog number
31319604
Device description
OR Towel,Green
Published
2018-06-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
NABGauze / sponge,nonresorbable for external use

Product Code Classifications

CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884521077413PackageGS180Not in Commercial Distribution
10884521077416PrimaryGS10
30884521077410Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088452107741320884521077413
1088452107741610884521077416
3088452107741030884521077410

GMDN Terms

TermDefinition
Surgical towelA sterile cloth used in the operating room (OR) to absorb extraneous fluids. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods

Method

Regulatory Flags

DUNS number
080935429
Device count
4
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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20884527020529Argyle888816035888881603582016-09-28
10884521000711Argyle888875001888887500182016-09-24
10884521000735Argyle888875051388887505132016-09-24
10884521011502Kangaroo888474121288847412122016-09-24
10884521011519Kangaroo888474121588847412152016-09-24
10884521011526Kangaroo888474122088847412202016-10-20
10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

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