FDA.reportPublic FDA data

SharpSafety

Primary DI
20884521067766
Brand
SharpSafety
Company
Cardinal Health, Inc.
Model
8554B
Catalog number
8554B
Device description
Wall Mounting Bracket
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOXSTAND, INFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521067766PrimaryGS10
30884521067763Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452106776620884521067766
3088452106776330884521067763

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884527009954Kendall30781747307817472018-06-23
30884527004748Kendall5000736150007361-2016-09-24
10884521021105MonojectSC5008XSC5008X2016-10-20
10884521021112MonojectSC6011XSC6011X2016-10-20
20884521152066Devon31145660311456602016-09-24
20884521152073Devon31145678311456782016-09-24
20884521152080Devon31145686311456862016-09-24
20884521152097Devon31145694311456942016-09-24
20884521152103Devon31145702311457022016-09-24
20884521152110Devon31145710311457102016-09-24
20884521152127Devon31145728311457282016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00761887005464PryorPRYOR PRODUCTSFOX2026-05-26
00810050863469AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00810050863476AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00761887005419PryorPRYOR PRODUCTSFOX2026-05-25
00761887005433PryorPRYOR PRODUCTSFOX2026-05-25
00761887005440Connected RockPRYOR PRODUCTSFOX2026-05-25
00761887005457CorCytePRYOR PRODUCTSFOX2026-05-25
09420012405913Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-23
00810050863377ServiPlexLIFEPORT, LLCFOX2026-02-19
00810050863384ServiPlexLIFEPORT, LLCFOX2026-02-19
00761887005372PhotonicarePRYOR PRODUCTSFOX2026-02-16
00761887005389PhotonicarePRYOR PRODUCTSFOX2026-02-16
04061162071280CIM med GmbHCIM med GmbHFOX2026-02-01
04061162071310CIM med GmbHCIM med GmbHFOX2026-02-01
00810050863360Transition DeckLIFEPORT, LLCFOX2026-01-27
04061162100096CIM med GmbHCIM med GmbHFOX2026-01-14
00841027103233Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2026-01-08
00761887005358BaxterPRYOR PRODUCTSFOX2026-01-05
00761887005341PryorPRYOR PRODUCTSFOX2025-12-31
00041298995166HealthSmartD-M-S HOLDINGS, INC.FOX2025-12-29
06973456941064CORITONCORITON Instrument Co.,LtdFOX2025-12-29
06973456941071CORITONCORITON Instrument Co.,LtdFOX2025-12-29
04061162087212CIM med GmbHCIM med GmbHFOX2025-12-14
04260217220332AMTRION Infusion S-0725-F-2-SAmtrion GmbHFOX2025-12-10
00841027103226Pedigo Products, Inc.PEDIGO PRODUCTS, INC.FOX2025-11-29
06973456941033CORITONCORITON Instrument Co.,LtdFOX2025-11-27
00841027100324Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102472Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102489Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26
00841027102496Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FOX2025-11-26