FDA.reportPublic FDA data

ARTISYN

Primary DI
10705031202795
Brand
ARTISYN
Company
Johnson & Johnson Medical GmbH
Model
ARTY
Catalog number
ARTY
Device description
Artisyn Y-Shaped Mesh
Published
2019-01-29
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
OTOMesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTOMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally PlacedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705031202795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503120279510705031202795

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic organ prolapse surgical mesh, composite-polymerA woven/knitted or porous material comprised of both a bioabsorbable polymer (e.g., poliglecaprone 25) and a non-bioabsorbable 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, trocars) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature030 Degrees Celsius
Storage Environment Temperature086 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
324368661
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031085862ULTRAPROUML1UML12019-01-25
10705031468641Coated VICRYLJ1036HJ1036H2022-06-27
10705031468672Coated VICRYLJ216HJ216H2022-06-27
10705031469075Coated VICRYLJ330HJ330H2022-06-27
10705031469723Coated VICRYLJ9441GJ9441G2022-07-11
10705031040274Coated VICRYLJ473HJ473H2015-09-01
10705031040335Coated VICRYLJ479HJ479H2015-09-01
10705031134195EndopathE705RLE705RL2016-07-01
10705031135451EndopathSRNH1LSRNH1L2016-07-01
10705031039117Coated VICRYLJ346HJ346H2015-09-01
10705031040373Coated VICRYLJ485HJ485H2015-09-01
10705031462892Coated VICRYLJV1069HJV1069H2022-12-28
30705031469727Coated VICRYLJ9441GJ9441G2022-07-11
30705031468645Coated VICRYLJ1036HJ1036H2022-06-27
30705031468676Coated VICRYLJ216HJ216H2022-06-27
30705031469079Coated VICRYLJ330HJ330H2022-06-27
10705031135178EndopathE705RE705R2016-07-01
10705031135208ETHICONEH40EH402018-02-21
10705031135444EndopathSRNH1SRNH12016-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00890594000056Desara Blue SLCaldera Medical, Inc.OTO2022-08-03
00890594000070Desara Blue SLCaldera Medical, Inc.OTO2022-08-03
00890594000339Vertessa Lite 10x22cm Caldera Medical, Inc.OTO2016-05-27
00890594000391Vertessa Lite Strips 4x22cmCaldera Medical, Inc.OTO2016-05-27
00890594000452Vertessa Lite Y 22x5x4cmCaldera Medical, Inc.OTO2016-05-27
00890594000704Desara Blue OVCaldera Medical, Inc.OTO2016-05-27
00890594000735Desara Blue Short Suture SlingCaldera Medical, Inc.OTO2016-05-27
00890594000643Vertessa Lite 10x22cm CALDERA MEDICAL, INC.OTO2016-05-27
00890594000360Vertessa Lite 10x26cmCaldera Medical, Inc.OTO2016-05-27
00890594000384Vertessa Lite Strips 4x22cmCALDERA MEDICAL, INC.OTO2016-05-27
00890594000421Vertessa Lite Y-mesh 22x4x3cmCaldera Medical, Inc.OTO2016-05-27
00890594000445Vertessa Lite Y 22x5x4cmCALDERA MEDICAL, INC.OTO2016-05-27
00890594000766Desara SLCaldera Medical, Inc.OTO2016-05-27
00890594000698Desara Blue OVCALDERA MEDICAL, INC.OTO2016-05-27
00890594000728Desara Blue Short Suture SlingCALDERA MEDICAL, INC.OTO2016-05-27
00089059400766Desara SLCALDERA MEDICAL, INC.OTO2016-05-27
00890594000674Desara BlueCaldera Medical, Inc.OTO2016-05-26
00890594000797Vertessa Lite Y-Mesh 26x5x4cmCaldera Medical, Inc.OTO2015-10-30
00890594000483Vertessa Lite Y-Mesh 26x4x3cmCaldera Medical, Inc.OTO2015-10-30
00890594000773Vertessa Lite Y-Mesh 26x5x4cmCALDERA MEDICAL, INC.OTO2015-10-30
05708932483223RestorelleColoplast A/SOTO2015-10-24
00814723020333IntePro Y-MeshENDO PHARMACEUTICALS INC.OTO2015-10-24
05708932483285RestorelleColoplast A/SOTO2015-10-22
05708932483834RestorelleColoplast A/SOTO2015-10-22
05708932483896RestorelleColoplast A/SOTO2015-10-22
05708932483964RestorelleColoplast A/SOTO2015-10-22
05708932528108RestorelleColoplast A/SOTO2015-10-22
05708932553773ColoplastColoplast A/SOTO2015-10-22
08714729839217Upsylon™BOSTON SCIENTIFIC CORPORATIONOTO2015-09-24
08714729839224Polyform™BOSTON SCIENTIFIC CORPORATIONOTO2015-09-24