Embrace Pen Needle 31G @5mm SHN02MM31.05

GUDID 00894030002116

Insulin pen needle 31G 5mm 100 ct.

OMNIS HEALTH, LLC

Autoinjector needle
Primary Device ID00894030002116
NIH Device Record Key213756cc-d832-4d4b-adc3-0ce388944547
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmbrace Pen Needle 31G @5mm
Version Model NumberSHN02MM31.05
Catalog NumberSHN02MM31.05
Company DUNS824763358
Company NameOMNIS HEALTH, 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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100894030002116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-12-07
Device Publish Date2022-11-29

Devices Manufactured by OMNIS HEALTH, LLC

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00894030002116 - Embrace Pen Needle 31G @5mm2022-12-07Insulin pen needle 31G 5mm 100 ct.
00894030002116 - Embrace Pen Needle 31G @5mm2022-12-07 Insulin pen needle 31G 5mm 100 ct.
00894030002123 - Embrace Pen Needle 31G @8mm2022-12-07 Insulin pen needle 31G 8mm 100 ct.
00894030002130 - Embrace Pen Needle 32G @4mm2022-12-07 Insulin pen needle 32G 4mm 100 ct.
00894030002529 - Embrace Pen Needle 30G @5mm2022-12-07 Insulin pen needle 30G 5mm 100 ct.

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