embecta Insulin Syringe 329461

GUDID 50383017946154

embecta™ Insulin Syringes, U-100, 12.7mm, 28G, 0.5mL

Embecta Medical II, LLC

Insulin syringe/needle, basic
Primary Device ID50383017946154
NIH Device Record Key7fff1ae1-c2f5-4b75-8729-21eaf6e1fcd7
Commercial Distribution StatusIn Commercial Distribution
Brand Nameembecta Insulin Syringe
Version Model Number329461
Catalog Number329461
Company DUNS118777356
Company NameEmbecta Medical II, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Needle Gauge28 Gauge
Length12.7 Millimeter
Needle Gauge28 Gauge
Length12.7 Millimeter
Needle Gauge28 Gauge
Length12.7 Millimeter
Needle Gauge28 Gauge
Length12.7 Millimeter
Needle Gauge28 Gauge
Length12.7 Millimeter
Needle Gauge28 Gauge
Length12.7 Millimeter
Needle Gauge28 Gauge
Length12.7 Millimeter
Needle Gauge28 Gauge
Length12.7 Millimeter
Needle Gauge28 Gauge
Length12.7 Millimeter
Needle Gauge28 Gauge
Length12.7 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110383017946118 [Primary]
GS130383017946136 [Package]
Contains: 10383017946118
Package: Carton [100 Units]
In Commercial Distribution
GS150383017946154 [Package]
Contains: 30383017946136
Package: Case [5 Units]
In Commercial Distribution

FDA Product Code

FMFSyringe, piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-02
Device Publish Date2024-11-22

On-Brand Devices [embecta Insulin Syringe]

50383017673050embecta™ Insulin Syringes, U-500, 6mm, 31G, 0.5mL
30383017946532embecta™ Insulin Syringes, U-100, 12.7mm, 28G, 0.5mL
50383017946154embecta™ Insulin Syringes, U-100, 12.7mm, 28G, 0.5mL
50383017942453embecta™ Insulin Syringes, U-100, 12.7mm, 28G, 1mL, 2 units
50383017942057embecta™ Insulin Syringes, U-100, 12.7mm, 28G, 1mL
50383017941258embecta™ Insulin Syringes, U-100, 16mm, 27G, 1mL
30383017941032embecta™ Insulin Syringes, U-100, 12.7mm, 28G, 1mL

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