FDA.reportPublic FDA data

Desara

Primary DI
00890594000889
Brand
Desara
Company
CALDERA MEDICAL, INC.
Model
CAL-DS01
Catalog number
CAL-DS01
Device description
Desara sling system for female stress urinary incontinence.
Published
2019-09-30
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132069000DESARA MESH, DESARA BLUECaldera Medical, Inc.2013-09-23OTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00890594000872PackageGS15In Commercial Distribution
00890594000889PackageGS11In Commercial Distribution
00890594000896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00890594000872008905940008728905940008720890594000872
00890594000889008905940008898905940008890890594000889
00890594000896008905940008968905940008960890594000896

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.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature in a clean, dry place. Do not expose product to direct sunlight, humid environments or extreme temperatures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-422-5337info@calderamedical.com
1-818-879-6555hello@calderamedical.com

Regulatory Flags#

DUNS number
130341956
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
true
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
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
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
00860003619810Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
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
00890594000858Desara Blue TVCaldera Medical, Inc.OTN2019-09-30
00890594000896DesaraCaldera Medical, Inc.OTN2019-09-30
00890594000902Desara TV Caldera Medical, Inc.OTN2019-09-30
00890594000841Desara Blue TVCALDERA 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