FDA.reportPublic FDA data

Restorelle

Primary DI
05708932483223
Brand
Restorelle
Company
Coloplast A/S
Model
501320
Catalog number
501320
Device description
Polypropylene Mesh for sacrocolposuspension/sacrocolpopexy - M
Published
2015-10-24
Public version status
Update
Distribution status
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
05708932483223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932483223057089324832235708932483223

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter
Width10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932135184Conveen05050050502023-01-17
05701780434133SenSura Mio1229101229102026-04-30
05701780434508SenSura Mio1229201229202026-04-30
05701780434843SenSura Mio1229601229602026-04-30
05701780435239SenSura Mio1229701229702026-04-30
05701780436328SenSura Mio Convex1367901367902026-04-30
05701780436977SenSura Mio Convex1373101373102026-04-30
05701780437066SenSura Mio Convex1373201373202026-04-30
05701780437127SenSura Mio Convex1373301373302026-04-30
05701780437561SenSura Mio Convex1680101680102026-04-30
05701780438384SenSura Mio Convex1680501680502026-04-30
05701780439923SenSura Mio Convex1682101682102026-04-30
05701780440462SenSura Mio Convex1682201682202026-04-30
05701780440875SenSura Mio Convex1682301682302026-04-30
05701780441292SenSura Mio Convex1682501682502026-04-30
05701780441926SenSura Mio Convex1682601682602026-04-30
05701780442572SenSura Mio Convex1682701682702026-04-30
05701780443074SenSura Mio Convex1683001683002026-04-30
05701780443371SenSura Mio Convex1683101683102026-04-30
05701780444026SenSura Mio Convex1683201683202026-04-30

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
10705031202795ARTISYNJohnson & Johnson Medical GmbHOTO2019-01-29
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
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