FDA.reportPublic FDA data

Supris

Primary DI
05708932490016
Brand
Supris
Company
Coloplast A/S
Model
93-4450
Catalog number
93-4450
Device description
Retropubic Sling System
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OTNmesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708932490016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932490016057089324900165708932490016

GMDN Terms#

Term, Definition table
TermDefinition
Stress urinary incontinence surgical mesh, femaleA sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may be referred to as a sling, tape, or subfascial hammock, and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., needles, sheaths) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932778268SpeediCath Flex Set28941289412026-02-05
05708932778275SpeediCath Flex Set28942289422026-02-05
05708932778282SpeediCath Flex Set28946289462026-02-05
03600040963876ColoplastAC5904AC59042026-01-30
03600040963944ColoplastAC5905AC59052026-01-30
03600040964026ColoplastAC5906AC59062026-01-30
03600040964095ColoplastAC5907AC59072026-01-30
03600040964170ColoplastAC5908AC59082026-01-30
03600040964231ColoplastAC5909AC59092026-01-30
03600040964293ColoplastAC5910AC59102026-01-30
03600040964361ColoplastAC5911AC59112026-01-30
03600040964415ColoplastAC5912AC59122026-01-30
03600040964651ColoplastAC5C07AC5C072026-01-30
03600040965894ColoplastACP205ACP2052026-01-30
03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
03600040966068ColoplastACP208ACP2082026-01-30
03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00890594000124Desara Blue TVez 3.0Caldera Medical, Inc.OTN2022-08-03
00890594000131Desara TVez 2.7Caldera Medical, Inc.OTN2022-08-03
00890594000155Desara TVez 3.0Caldera Medical, Inc.OTN2022-08-03
00890594000193Desara Blue TVez 2.7Caldera Medical, Inc.OTN2022-08-03
00890594000087Desara Blue TVez 3.0Caldera Medical, Inc.OTN2021-11-15
00890594000094Desara Blue TVez 2.7Caldera Medical, Inc.OTN2021-11-15
00890594000100Desara TVez 2.7Caldera Medical, Inc.OTN2021-11-15
00890594000117Desara TVez 3.0Caldera Medical, Inc.OTN2021-11-15
00191506007652Advantage Ultra SystemBOSTON SCIENTIFIC CORPORATIONOTN2021-10-06
00191506007669Advantage Fit Ultra SystemBOSTON SCIENTIFIC CORPORATIONOTN2021-10-06
00191506007676Lynx Ultra SystemBOSTON SCIENTIFIC CORPORATIONOTN2021-10-06
00860003619803Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
20860003619814Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
00860003619827Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
08437007606027Remeex System (for Female Urinary Incontinence)DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606065KIM (Knotless Incontinence Mesh)DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606072Remeex System -Readjustment kit DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606263Remeex System - Thread PasserDESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606683KIM (Knotless Incontinence Mesh)DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606836Remeex System - Passer Handle DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
00890594000841Desara Blue TVCALDERA MEDICAL, INC.OTN2019-09-30
00890594000889DesaraCALDERA MEDICAL, INC.OTN2019-09-30
00890594000919Desara TV CALDERA MEDICAL, INC.OTN2019-09-30
00860368002401ArcTV™ Transvaginal Sling SystemUROCURE LLCOTN2019-08-13
08714729961918Advantage™ Blue SystemBOSTON SCIENTIFIC CORPORATIONOTN2018-01-22
08714729961925Advantage Fit™ Blue SystemBOSTON SCIENTIFIC CORPORATIONOTN2018-01-22
08714729961932Lynx™ Blue SystemBOSTON SCIENTIFIC CORPORATIONOTN2018-01-22
03760151650048I-STOPCL MEDICALOTN2017-05-19
03760151650055I-STOPCL MEDICALOTN2017-05-19
03760151650093I-STOPCL MEDICALOTN2017-05-19