TestoPak

GUDID 00367979723003

ENDO PHARMACEUTICALS INC.

General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use
Primary Device ID00367979723003
NIH Device Record Keyc2cc2b83-8edc-488c-a104-cb57f45ba9a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTestoPak
Version Model NumberTestoPak
Company DUNS178074951
Company NameENDO PHARMACEUTICALS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
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
GS100367979723003 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-06
Device Publish Date2018-06-05

Devices Manufactured by ENDO PHARMACEUTICALS INC.

00367979855001 - N/A2021-03-04
00367979002009 - Supprelin LA2019-07-12 Supprelin Kit
00367979005000 - Vantas2019-07-12
00814723020036 - MiniArc2019-04-23 MiniArc
00814723020104 - MiniArc2019-04-23 MiniArc Precise
00814723020296 - SPARC2019-04-23 SPARC
00814723020319 - Monarc2019-04-23 Monarc
00814723020340 - Monarc2019-04-23 Monarc +

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.