FDA.reportPublic FDA data

Member's Mark pen needles 31G 8mm

Primary DI
00078742257754
Brand
Member's Mark pen needles 31G 8mm
Company
WAL-MART STORES, INC.
Model
31G x 8 mm
Catalog number
8933
Device description
Sterile, single use pen needles.Intended to be used with pen injector device for the subcutaneous injection of insulin.
Published
2017-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20078742257758PackageGS130In Commercial Distribution
00078742257754PrimaryGS10
10078742257751Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2007874225775820078742257758
00078742257754000787422577540787422577540078742257754
1007874225775110078742257751

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051957769
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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