FDA.reportPublic FDA data

Supprelin LA

Primary DI
00367979002009
Brand
Supprelin LA
Company
ENDO PHARMACEUTICALS INC.
Model
6797900200
Device description
Supprelin Kit
Published
2018-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00367979002009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00367979002009003679790020093679790020090367979002009

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous implantation kit, medicatedA collection of various surgical instruments and materials, including a pharmaceutical component (e.g., local anaesthetic), intended for subcutaneous delivery of an implantable drug pellet/implant (not included). It typically includes a dedicated implantation tool/cannula with non-dedicated supportive devices (e.g., dressings, drapes, clamps). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
178074951
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00367979855001N/A9 Gauge Disposable Trocar with Blunt Pusher (501342021-02-24
00367979723003TestoPakTestoPak2018-06-05
00814723020036MiniArc720046-01720046-012015-10-24
00814723020104MiniArc720191-01720191-012015-10-24
00814723020296SPARC72403656724036562015-10-24
00814723020319Monarc72403830724038302015-10-24
00814723020340Monarc72404193724041932015-10-24
00814723020357Monarc 72404195724041952015-10-24
00814723020364MiniArc900026190002612015-10-24
00814723020371RetroArc900026290002622015-10-24
00814723020401NA100624110062412015-10-24
00814723020425SPARC100622810062282015-10-24
00814723020449Monarc 100622910062292015-10-24
00814723020463Monarc100623010062302015-10-24
00814723020487Monarc100623110062312015-10-24
00814723020494RetroArc100634610063462015-10-24
00367979005000VantasModel 0012018-06-05
00367979001002ValstarN/A2018-06-05
00814723020050Elevate720093-01720093-012015-10-24
00814723020067Elevate720127-01720127-012015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422806MillenniumAvalign Technologies, Inc.MDM2026-08-03
00198506092350ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506093197ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506093586ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
00198506090561ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092589ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092671ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092695ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092701ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092718ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092725ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093012ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093029ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093111ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093166ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093203ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093296ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093364ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093371ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093425ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093432ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506093463ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-28
00198506092039ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092046ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092398ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092404ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092411ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00198506092428ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-27
00840456202104JMUJMU DENTAL, INCMDM2026-07-27
00840456215760JMUJMU DENTAL, INCMDM2026-07-27