inControl /UltiCare

GUDID 20412206068700

inControl 4mm Pen Needle UltiGuard

H. E. BUTT GROCERY COMPANY

Autoinjector needle Autoinjector needle
Primary Device ID20412206068700
NIH Device Record Key634612bb-062c-449b-b291-f737f9e2f9e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameinControl /UltiCare
Version Model Number757011
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
GS100357515710031 [Unit of Use]
GS120412206068700 [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 Number2
Public Version Date2018-07-06
Device Publish Date2018-05-18

Devices Manufactured by H. E. BUTT GROCERY COMPANY

00441220245978 - H-E-B2023-11-13 HEB 20 SECOND FLEX TIP DIGITAL THERMOMETER FAHRENHEIT
00041220924837 - H-E-B2023-11-13 8 SECOND ULTRA STICK THERMOMETER
10041220549754 - H.E.B2023-11-07 HEB 5D CASSETTE
00041220103157 - H.E.B 2023-07-06 FPPL HEB DPS +/-
00041220524433 - H.E.B 2023-07-06 FPPL HEB DPS +/-
10041220524447 - H.E.B 2023-07-06 CB8 HEB DPS Digital Early 2ct
10041220558046 - H.E.B 2023-07-06 PLPL HEB DPS Early Result Pink Cap
00384703590007 - H.E.B. Unifine Pentips2023-06-28 HEB Unifine Pentips pen needles, 6mm x 31G

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