FDA.reportPublic FDA data

Desara Blue TVez 2.7

Primary DI
00890594000193
Brand
Desara Blue TVez 2.7
Company
Caldera Medical, Inc.
Model
CAL-DS01BTV27
Device description
Desara Blue TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence
Published
2022-08-03
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
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
PWJInstrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorGeneral, Plastic Surgery2
PWJInstrumentation, Surgical Mesh, Urogynecologic, Stress Urinary IncontinenceObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211975000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211975000Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc.2021-11-10OTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00890594000193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00890594000193008905940001938905940001930890594000193

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.

Sterilization Methods#

Method table
Method

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
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
00890594000216Transobturator Hook IntroducerCAL-TB03CAL-TB032019-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857492008003Transobturator Helical, Left IntroducerCaldera Medical, Inc.PWJ2022-08-03
00857492008010Transobturator Helical, Right IntroducerCaldera Medical, Inc.PWJ2022-08-03
00890594000124Desara Blue TVez 3.0Caldera Medical, Inc.OTN2022-08-03
00890594000124Desara Blue TVez 3.0Caldera Medical, Inc.PWJ2022-08-03
00890594000131Desara TVez 2.7Caldera Medical, Inc.OTN2022-08-03
00890594000131Desara TVez 2.7Caldera Medical, Inc.PWJ2022-08-03
00890594000155Desara TVez 3.0Caldera Medical, Inc.OTN2022-08-03
00890594000155Desara TVez 3.0Caldera Medical, Inc.PWJ2022-08-03
00890594000087Desara Blue TVez 3.0Caldera Medical, Inc.OTN2021-11-15
00890594000087Desara Blue TVez 3.0Caldera Medical, Inc.PWJ2021-11-15
00890594000094Desara Blue TVez 2.7Caldera Medical, Inc.PWJ2021-11-15
00890594000094Desara Blue TVez 2.7Caldera Medical, Inc.OTN2021-11-15
00890594000100Desara TVez 2.7Caldera Medical, Inc.PWJ2021-11-15
00890594000100Desara TVez 2.7Caldera Medical, Inc.OTN2021-11-15
00890594000117Desara TVez 3.0Caldera Medical, Inc.PWJ2021-11-15
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
00890594000957Desara One Caldera Medical, Inc.PWJ2020-02-25