FDA.reportPublic FDA data

SHOPKO Unifine Pentips Plus - 12mmx29G pen needles

Primary DI
00761059821557
Brand
SHOPKO Unifine Pentips Plus - 12mmx29G pen needles
Company
Shopko
Model
AN 3829SKO
Catalog number
AN 3829SKO
Device description
For use with injectors for the subcutaneous injection of approved drugs, including insulin
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152339000Unifine Pentips/ Unifine Pentips PlusOwen Mumford, Ltd.2016-06-24FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00761059820550PackageGS16In Commercial Distribution
00761059821557PackageGS124In Commercial Distribution
00761059829553PrimaryGS10
00761059829000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00761059820550007610598205507610598205500761059820550
00761059821557007610598215577610598215570761059821557
00761059829553007610598295537610598295530761059829553
00761059829000007610598290007610598290000761059829000

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length12Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
920-429-2211xx@xx.xx

Regulatory Flags#

DUNS number
023252638
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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00400131052266Shopko TamponsBSKGR202016-09-20
00400131052594Shopko TamponsBSKGS182016-09-20
00400265046964Shopko TamponsBSKUR182017-10-02
00400265047121Shopko TamponsBSKPC342017-10-02
00400265047206Shopko TamponsBSKPP342017-10-02
00400265047381Shopko TamponsBSKGR362017-10-02
00400265047466Shopko TamponsBSKGS362017-10-02
00400265047534Shopko TamponsBSKGS182017-10-02
00400265047046Shopko TamponsBSKUS182017-10-02
10400131052263Shopko TamponsBSKGR202016-09-20
10400131052591Shopko TamponsBSKGS182016-09-20
10400265047128Shopko TamponsBSKPC342017-10-02
10400265047203Shopko TamponsBSKPP342017-10-02
10400265047388Shopko TamponsBSKGR362017-10-02
10400265047463Shopko TamponsBSKGS362017-10-02
10400265047531Shopko TamponsBSKGS182017-10-02
00761059829553SHOPKO Unifine Pentips Plus - 12mmx29G pen needlesAN 3829SKOAN 3829SKO2016-09-19
00761059830559SHOPKO Unifine Pentips Plus - 8mmx31G pen needlesAN 3830SKOAN 3830SKO2016-09-19
00761059840558SHOPKO Unifine Pentips Plus - 4mmx32G pen needlesAN 3840SKOAN 3840SKO2016-09-19
00761059850557SHOPKO Unifine Pentips Plus - 5mmx31G pen needlesAN 3850SKOAN 3850SKO2016-09-19

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