FDA.report

SharpSafety

Primary DI
10884521115941
Brand
SharpSafety
Company
Cardinal Health, Inc.
Model
8912SA
Catalog number
8912SA
Device description
Non-Locking Bracket,For Phlebotomy Container,1 Quart
Published
2018-06-27
Public version status
Update
Distribution status
Not 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
10884521115941PrimaryGS10
20884521115948Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088452111594110884521115941
2088452111594820884521115948

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.

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
5
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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10884521011557Kangaroo888474123588847412352016-09-24
10884521011595Kangaroo888474164988847416492016-09-24

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