FDA.reportPublic FDA data

EXEL Comfort Point Insulin Pen Needles

Primary DI
20020221260063
Brand
EXEL Comfort Point Insulin Pen Needles
Company
Exel International
Model
26006
Catalog number
26006
Device description
Insulin Pen Needle, 31G x 1/6
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
20020221260063PackageGS112Not in Commercial Distribution
10020221260066PrimaryGS10
00020221260069Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2002022126006320020221260063
1002022126006610020221260066
00020221260069000202212600690202212600690020221260069

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
180572216
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
00020221017809EXEL 1mL CARRYING AND DELIVERY SYRINGEOSTDS1OSTDS12023-04-21
00020221262674EXEL CURVED TIP SYRINGE26267262672023-03-15
00020221263053EXEL Disposable Syringes26305263052026-02-24
00020221260403EXEL Syringes26040260402016-09-20
00020221260427EXEL Syringes26042260422016-09-20
00020221260434EXEL Syringes26043260432016-09-20
00020221260441EXEL Syringes26044260442016-09-20
00020221260458"EXEL 1ml SYRINGE 26Gx3/8"" L-S"26045260452023-03-15
00020221260489EXEL Syringes26048260482016-09-20
00020221260496EXEL Syringes26049260492016-09-20
00020221260502EXEL Syringes26050260502016-09-20
00020221260519"EXEL 1mL TB 21Gx1""-0-DEAD-SPACE"26051260512023-03-15
00020221260663"EXEL 1ml SYRINGE 25Gx1""-0-DEAD-SPACE"26066260662023-03-15
00020221260670"EXEL 1ml SYRINGE 23Gx1""-0-DEAD-SPACE"26067260672023-03-15
00020221261004EXEL Syringes26100261002016-09-20
00020221261011EXEL Syringes26101261012016-09-20
00020221261028EXEL Syringes26102261022016-09-20
00020221261035EXEL Syringes26103261032016-09-20
00020221261042EXEL Syringes26104261042016-09-20
00020221261059EXEL Syringes26105261052016-09-20

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