embecta Insulin Syringe 329412

GUDID 50383017941258

embecta™ Insulin Syringes, U-100, 16mm, 27G, 1mL

Embecta Medical II, LLC

Insulin syringe/needle, basic
Primary Device ID50383017941258
NIH Device Record Key10b95319-8eb9-4591-8d61-300bf0821187
Commercial Distribution StatusIn Commercial Distribution
Brand Nameembecta Insulin Syringe
Version Model Number329412
Catalog Number329412
Company DUNS118777356
Company NameEmbecta Medical II, LLC
Device Count10
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 Gauge27 Gauge
Length16 Millimeter
Needle Gauge27 Gauge
Length16 Millimeter
Needle Gauge27 Gauge
Length16 Millimeter
Needle Gauge27 Gauge
Length16 Millimeter
Needle Gauge27 Gauge
Length16 Millimeter
Needle Gauge27 Gauge
Length16 Millimeter
Needle Gauge27 Gauge
Length16 Millimeter
Needle Gauge27 Gauge
Length16 Millimeter
Needle Gauge27 Gauge
Length16 Millimeter
Needle Gauge27 Gauge
Length16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110383017941212 [Primary]
GS130383017941230 [Package]
Contains: 10383017941212
Package: Carton [10 Units]
In Commercial Distribution
GS150383017941258 [Package]
Contains: 30383017941230
Package: Case [5 Units]
In Commercial Distribution
GS180383017941280 [Unit of Use]

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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