FDA.reportPublic FDA data

Desara Blue Short Suture Sling

Primary DI
00890594000735
Brand
Desara Blue Short Suture Sling
Company
Caldera Medical, Inc.
Model
CAL-DS01BS
Device description
Desara® Blue Short Suture Sling for female stress urinary incontinence
Published
2016-05-27
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140843000DESARA BLUE OV, DESARA BLUE SSCaldera Medical2014-07-01OTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00890594000711PackageGS15In Commercial Distribution
00890594000728PackageGS11In Commercial Distribution
00890594000735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00890594000711008905940007118905940007110890594000711
00890594000728008905940007288905940007280890594000728
00890594000735008905940007358905940007350890594000735

GMDN Terms#

Term, Definition table
TermDefinition
Female stress urinary incontinence surgical mesh-sling, synthetic polymerA woven/knitted or porous strip of 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 also be referred to as a tape or subfascial hammock. Disposable devices associated with implantation may be supplied with the mesh-sling.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00This product must be stored at room temperature in a clean dry place. Do not expose product to direct sunlight, humid environments, or extreme temperatures. Do not use after expiration date.

Contacts#

Phone, Email table
PhoneEmail
1-818-879-6555hello@calderamedical.com

Regulatory Flags#

DUNS number
130341956
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
00857492008164Benesta Hysteroscope Adapter CAL-TR14312022-07-19
00890594000124Desara Blue TVez 3.0CAL-DS01BTV302022-08-03
00890594000131Desara TVez 2.7CAL-DS01TV272022-08-03
00890594000155Desara TVez 3.0CAL-DS01TV302022-08-03
00890594000193Desara Blue TVez 2.7CAL-DS01BTV272022-08-03
00890594000087Desara Blue TVez 3.0CAL-DS01BTV302021-11-15
00890594000094Desara Blue TVez 2.7CAL-DS01BTV272021-11-15
00890594000100Desara TVez 2.7CAL-DS01TV272021-11-15
00890594000117Desara TVez 3.0CAL-DS01TV302021-11-15
00890594000230Transvaginal 4.0 mm IntroducerCAL-TV02CAL-TV022019-09-30
00890594000865Transvaginal 3.2 mm IntroducerCAL-TV32CAL-TV322019-09-30
00857492008041Benesta Hysteroscope SetCAL-TR1112022-08-03
00890594000933Transobturator Inside-Out, Right 3.2 mm IntroducerCAL-IOR32CAL-IOR322019-11-05
00890594000940Transobturator Inside-Out, Left 3.2 mm IntroducerCAL-IOL32CAL-IOL322019-11-05
00890594000018Transobturator Helical, Left IntroducerCAL-HL04CAL-HL042019-09-30
00890594000148Transobturator Helical, Right IntroducerCAL-HR05CAL-HR052019-09-30
00890594000162Transobturator Large Helical, Left IntroducerCAL-LHL1CAL-LHL12019-09-30
00890594000179Transobturator Large Helical, Right IntroducerCAL-LHR2CAL-LHR22019-09-30
00890594000186Transobturator Inside-Out, Left IntroducerCAL-IO6CAL-IO62019-09-30
00890594000209Transobturator Inside-Out, Right IntroducerCAL-IO7CAL-IO72019-09-30

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
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