FDA.reportPublic FDA data

Wegman's Unifine Pentips Plus - 4mmx32G

Primary DI
00077890352373
Brand
Wegman's Unifine Pentips Plus - 4mmx32G
Company
WEGMANS FOOD MARKETS, INC.
Model
AN 3840WEG
Catalog number
AN 3840WEG
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
00761059841548PackageGS16In Commercial Distribution
00761059842545PackageGS124In Commercial Distribution
00077890352373PrimaryGS10
00384703840000Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00761059841548007610598415487610598415480761059841548
00761059842545007610598425457610598425450761059842545
00077890352373000778903523730778903523730077890352373
00384703840000003847038400003847038400000384703840000

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
Length4Millimeter
Needle Gauge32Gauge

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
800-934-6267xx@xx.xx

Regulatory Flags#

DUNS number
059650069
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00077890322581Wegman's Unifine Pentips Plus - 8mmx31GAN 3830WEGAN 3830WEG2016-09-19
00077890322567Wegman's Unifine Pentips Plus - 5mmx31GAN 3850WEGAN 3850WEG2016-09-19
00077890322574Wegman's Unifine Pentips Plus - 6mmx31GAN 3890WEGAN 3890WEG2016-09-19
00761059832546Wegman's Unifine Pentips Plus - 8mmx31GAN 3830WEGAN 3830WEG2016-09-19

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