FDA.reportPublic FDA data

South Pointe Wholesale - Unifine Pentips

Primary DI
00761059551850
Brand
South Pointe Wholesale - Unifine Pentips
Company
OWEN MUMFORD USA INCORPORATED
Model
AN 3550SPW
Device description
1st Tier 5mm x 31g pen needles
Published
2021-11-05
Public version status
New
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
00761059551850PackageGS110In Commercial Distribution
00761059552857PackageGS15In Commercial Distribution
00761059550853PrimaryGS10
00384703530003Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00761059551850007610595518507610595518500761059551850
00761059552857007610595528577610595528570761059552857
00761059550853007610595508537610595508530761059550853
00384703530003003847035300033847035300030384703530003

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
Length6Millimeter
Needle Gauge31Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-977-2226USCustomerService@owenmumford.com

Regulatory Flags#

DUNS number
803401454
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384701604010Unistik Pro PlusAT 16042025-09-16
00384703160019EmpelvicSM 31602025-08-22
00384703150010EmpelvicSM 31502025-08-22
00384703155015EmpelvicSM 31552025-08-22
00761059640004Unifine OTCAN 36402025-02-14
00761059641001Unifine OTCAN 36412025-02-14
00761059650003Unifine OTCAN 36502025-02-14
00761059651000Unifine OTCAN 36512025-02-14
00761059640028Unifine OTCAN 36402025-02-14
00761059641032Unifine OTCAN 36412025-02-14
00761059650027Unifine OTCAN 36502025-02-14
00761059651031Unifine OTCAN 36512025-02-14
00761059507093Unifine PentipsAN 3550AC2024-05-17
00761059359012Unifine PentipsAN 3590AC2024-02-21
00761059354000Unifine PentipsAN 3540AC2024-02-05
00761059354024Unifine PentipsAN 3540AC2024-02-05
00761059352914Unifine PentipsAN 3529AC2024-01-22
00761059352921Unifine PentipsAN 3529AC2024-01-22
00384707001011Unistik VacuFlipBC 70012023-10-06
00384707102015Unistik VacuFlipBC 71022023-10-06

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