FDA.reportPublic FDA data

Good Sense Penfine Classic Pen Needles

Primary DI
20370030125290
Brand
Good Sense Penfine Classic Pen Needles
Company
L PERRIGO COMPANY
Model
700014598
Device description
Sterile, single-use, 3-bevel pen needles, 31 Gauge, 8mm (5/16") Length, extra-thin wall
Published
2019-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
20370030125290PackageGS120In Commercial Distribution
00370030125296PrimaryGS10
10370030125293Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2037003012529020370030125290
00370030125296003700301252963700301252960370030125296
1037003012529310370030125293

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006013346
Device count
90
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
00070030147655Good Sense7W926C2C12022-10-11
00070030511739SCARAWAY SILICONE GEL 20G11A3QSAC12021-03-17
00070030165536SCARAWAY SILICONE GEL 20G11A3QSAC12021-03-17
00070030510718Comfort Assist Insulin Syringe1030082016-09-24
00070030510725Comfort Assist Insulin Syringe0331082016-09-24
00070030510732Comfort Assist Insulin Syringe0531082016-09-24
00070030510749Comfort Assist Insulin Syringe1029122016-09-24
00070030510756Comfort Assist Insulin Syringe0330082016-09-24
00070030510763Comfort Assist Insulin Syringe0530082016-09-24
00070030510770Comfort Assist Insulin Syringe1031082016-09-24
00370030128709GoodSense Comfort Assist Insulin Syringes0529122016-09-24
00370030128716GoodSense Comfort Assist Insulin Syringes1030082016-09-24
00370030128723GoodSense Comfort Assist Insulin Syringes0331082016-09-24
00370030128730GoodSense Comfort Assist Insulin Syringes0531082016-09-24
00370030128747GoodSense Comfort Assist Insulin Syringes0330082016-09-24
00370030128754GoodSense Comfort Assist Insulin Syringes0530082016-09-24
00370030128761GoodSense Comfort Assist Insulin Syringes1031082016-09-24
10370030128706GoodSense Comfort Assist Insulin Syringes0529122016-09-24
10370030128713GoodSense Comfort Assist Insulin Syringes1030082016-09-24
10370030128720GoodSense Comfort Assist Insulin Syringes0331082016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840464800019Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800064Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08800145524667JBP Nanocannula 23Gx40mmFeeltech Co.,Ltd.FMI2026-04-16
08800052609242Sure Fine Pen Needle 32G x 4mmSHINA MED CORPORATIONFMI2026-03-25
08800052609259Sure Fine Pen Needle 31G x 8mmSHINA MED CORPORATIONFMI2026-03-25
08800052609266Sure Fine Pen Needle 32G x 6mmSHINA MED CORPORATIONFMI2026-03-25
08800052609273"Sure Fine Pen Needle 30G x 5/16"""SHINA MED CORPORATIONFMI2026-03-25
08800052609280Sure Fine Pen Needle 31G 5mmSHINA MED CORPORATIONFMI2026-03-25
08800052609297"Sure Fine Pen Needle 29G x 1/2"""SHINA MED CORPORATIONFMI2026-03-25
08720865786063Bella-muU-Needle B.V.FMI2025-10-29
08586015049729SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049743SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586015049767SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03
08586026571417SelfinjectCHIRANA T.Injecta, a. s.FMI2025-10-03