Elevate

Primary DI
00814723020050
Brand
Elevate
Company
ENDO PHARMACEUTICALS INC.
Model
720093-01
Catalog number
720093-01
Device description
Elevate Anterior & Apical
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally PlacedObstetrics/Gynecology3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814723020050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814723020050008147230200508147230200500814723020050

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic organ prolapse surgical mesh, synthetic polymerA sterile woven/knitted or porous material comprised of a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor for the surgical treatment of vaginal pelvic organ prolapse (POP), including anterior, posterior, or apical prolapse repair. It is typically available with various material attributes (e.g., density, pore size, weave) and may be pre-configured for specific repair or cut to desired size/shape. Disposable devices associated with implantation (e.g., introducer needles) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store product in a clean, dry, dark area at room temperature.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18448790787crabtree.tim@endo.com

Regulatory Flags#

DUNS number
178074951
Device count
1
Lot or batch
true
Manufacturing date on label
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
00367979002009Supprelin LA67979002002018-06-05
00367979005000VantasModel 0012018-06-05
00367979001002ValstarN/A2018-06-05
00814723020067Elevate720127-01720127-012015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814723020067ElevateENDO PHARMACEUTICALS INC.OTP2015-10-24
05708932459433ExairColoplast A/SOTP2015-10-22
05708932459457ExairColoplast A/SOTP2015-10-22
08714729839200Uphold™ LITEBOSTON SCIENTIFIC CORPORATIONOTP2015-09-24