FDA.reportPublic FDA data

Wegman's Unifine Pentips Plus - 8mmx31G

Primary DI
00761059832546
Brand
Wegman's Unifine Pentips Plus - 8mmx31G
Company
WEGMANS FOOD MARKETS, INC.
Model
AN 3830WEG
Catalog number
AN 3830WEG
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
00761059831549PackageGS16In Commercial Distribution
00761059832546PackageGS124In Commercial Distribution
00077890322581PrimaryGS10
00384703830001Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00761059831549007610598315497610598315490761059831549
00761059832546007610598325467610598325460761059832546
00077890322581000778903225810778903225810077890322581
00384703830001003847038300013847038300010384703830001

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
Length8Millimeter

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
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
true
Sterilization required before use
false

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
00077890352373Wegman's Unifine Pentips Plus - 4mmx32GAN 3840WEGAN 3840WEG2016-09-19

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