inControl/UltiCare

GUDID 20041220606911

8mm inControl/UltiCare Pen Needle UltiGuard

H. E. BUTT GROCERY COMPANY

Autoinjector needle
Primary Device ID20041220606911
NIH Device Record Keyf377f312-539f-4713-b388-4e4a73df529e
Commercial Distribution StatusIn Commercial Distribution
Brand NameinControl/UltiCare
Version Model Number907722
Company DUNS007924756
Company NameH. E. BUTT GROCERY COMPANY
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100357515710055 [Unit of Use]
GS120041220606911 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-12
Device Publish Date2018-05-18

On-Brand Devices [inControl/UltiCare]

204122060691728mm inControl/UltiCare Pen Needle UltiGuard
204122060689466mm inControl/UltiCare Pen Needle UltiGuard
200412206069118mm inControl/UltiCare Pen Needle UltiGuard
00357515710048InControl 6mm pen needle UltiGuard

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