Nano 2nd Gen 320550

GUDID 50383017055054

Nano™ 2nd Gen Pen Needles, 4mm, 32G, 5bevel, UTW

Embecta Medical II, LLC

Autoinjector needle
Primary Device ID50383017055054
NIH Device Record Key047f66e6-1512-4f7e-8a02-f859746a0806
Commercial Distribution StatusIn Commercial Distribution
Brand NameNano 2nd Gen
Version Model Number320550
Catalog Number320550
Company DUNS118777356
Company NameEmbecta Medical II, LLC
Device Count100
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-Countertrue

Device Dimensions

Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100383017055035 [Primary]
GS150383017055054 [Package]
Contains: 00383017055035
Package: Case [12 Units]
In Commercial Distribution
GS180383017055086 [Unit of Use]

FDA Product Code

FMINeedle, hypodermic, single lumen

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 [Nano 2nd Gen]

50383017055054Nano™ 2nd Gen Pen Needles, 4mm, 32G, 5bevel, UTW
50383017057454Nano™ 2nd Gen Pen Needles, 4mm, 32G, 5bevel, UTW
50383017055153Nano™ 2nd Gen Pen Needles, 4mm, 32G, 5bevel, UTW

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.