NEEDLES 25x1

GUDID 00369771001853

NEEDLES 25x1

GERI-GENTLE CORPORATION

Medication cartridge syringe, safety-needle
Primary Device ID00369771001853
NIH Device Record Keya6c3f61b-db35-4e50-9541-0decce704a0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEEDLES 25x1
Version Model Number11-251
Company DUNS361663839
Company NameGERI-GENTLE CORPORATION
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 Datefalse
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
GS100369771001846 [Primary]
GS100369771001853 [Package]
Contains: 00369771001846
Package: Inner [100 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 Date2021-01-11
Device Publish Date2021-01-01

Devices Manufactured by GERI-GENTLE CORPORATION

00369771003659 - Sharps Collector 5QT2023-11-09 Sharps Collector 5QT
00369771003390 - Pen Needle2023-09-11 Safety Pen Needle 30G
00369771003437 - Prefilled Syrings2023-09-11 10ML PREFILLED SYRINGE
00369771003161 - Oxygen Concentrator2023-08-09 Oxygen Concentrator
20369771000782 - Lancets Safety2023-08-09 Lancets Safety
00369771003123 - SYRINGE RETRACT U100 1cc 29x.52023-07-10 SYRINGE RETRACT U100 1cc 29x.5
20369771000898 - Syringes Safety2023-02-22 SYR U100 1cc 29x.5
20369771000904 - Syringes Safety2023-02-22 SYR U100 .5cc 29x.5

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