Supprelin LA

GUDID 00367979002009

Supprelin Kit

ENDO PHARMACEUTICALS INC.

Subcutaneous implantation kit, medicated
Primary Device ID00367979002009
NIH Device Record Key03444352-2563-48b5-adde-c60cf44646ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameSupprelin LA
Version Model Number6797900200
Company DUNS178074951
Company NameENDO PHARMACEUTICALS INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100367979002009 [Primary]

FDA Product Code

MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-07-12
Device Publish Date2018-06-05

Devices Manufactured by ENDO PHARMACEUTICALS INC.

00367979855001 - N/A2021-03-04
00367979002009 - Supprelin LA2019-07-12Supprelin Kit
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 +

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