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
Rx
false
OTC
false
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
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00681131106092Equate5997602702026-02-25
00068113110610Equate5998092362026-02-25
00193968604929Member's Mark9905130552026-02-18
00194346604845EquateVI100162026-02-16
20681131045647EquateWAL4245VWAL4245V2026-01-29
10194346614049EquateHTD8210US2026-01-21
00194346539802Equate1943465398022026-01-05
00194346539819Equate1943465398192026-01-05
00194346615124EquateWart Remover2025-12-22
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10193968477827Member's MarkSAM18V2SAM18V22025-12-19
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