FDA.report

SharpSafety

Primary DI
10884521067653
Brand
SharpSafety
Company
Cardinal Health, Inc.
Model
8980FP
Catalog number
8980FP
Device description
Foot Pedal Cart,For Hinged Lid Container
Published
2018-06-27
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
false

Related Records

Contact Domains

Product Codes

CodeName
FOXSTAND, INFUSION

Product Code Classifications

CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884521067653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088452106765310884521067653

GMDN Terms

TermDefinition
Surgical clip rackA device typically designed as a container used to hold and protect implantable clips during the sterilization process. The rack also serves to hold the clips in the proper geometric orientation to permit mating with the clip applier used during the clip's application. This is a reusable device.

Device Sizes

TypeValueUnit
Total Volume8Gallon

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods

Method

Contacts

PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags

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

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10884521011533Kangaroo888474122588847412252016-09-24
10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

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