Lancets Safety

GUDID 20369771000782

Lancets Safety

GERI-GENTLE CORPORATION

Manual blood lancing device, single-use
Primary Device ID20369771000782
NIH Device Record Keyc57fb062-56c9-49b4-8a30-8dee8dee0c87
Commercial Distribution StatusIn Commercial Distribution
Brand NameLancets Safety
Version Model Number25-457
Company DUNS361663839
Company NameGERI-GENTLE CORPORATION
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100369771000788 [Unit of Use]
GS110369771000785 [Primary]
GS120369771000782 [Package]
Contains: 10369771000785
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-09
Device Publish Date2023-08-01

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 Safety2023-08-09Lancets Safety
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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