H.E.B. Unifine Pentips

GUDID 30041220981336

HEB Unifine Pentips Plus pen needles, 5mm x 31G

H. E. BUTT GROCERY COMPANY

Autoinjector needle
Primary Device ID30041220981336
NIH Device Record Keyacaa7a14-5017-4750-8f4f-6f39cbf4df8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameH.E.B. Unifine Pentips
Version Model NumberAN 3550HEB
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-Countertrue

Device Dimensions

Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100041220981335 [Primary]
GS100384703550001 [Unit of Use]
GS130041220981336 [Package]
Contains: 00041220981335
Package: Sleeve [10 Units]
In Commercial Distribution
GS150041220981330 [Package]
Package: Case [5 Units]
In Commercial Distribution

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 Date2023-06-28
Device Publish Date2023-06-20

On-Brand Devices [H.E.B. Unifine Pentips ]

00384703550001HEB Unifine Pentips, 8mm x 31G
30041220981336HEB Unifine Pentips Plus pen needles, 5mm x 31G
00384703590007HEB Unifine Pentips pen needles, 6mm x 31G

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