FDA.reportPublic FDA data

Transobturator Inside-Out, Right 3.2 mm Introducer

Primary DI
00890594000933
Brand
Transobturator Inside-Out, Right 3.2 mm Introducer
Company
Caldera Medical, Inc.
Model
CAL-IOR32
Catalog number
CAL-IOR32
Device description
Transobturator Inside-Out, Right 3.2 mm Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh.
Published
2019-11-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PWJInstrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWJInstrumentation, Surgical Mesh, Urogynecologic, Stress Urinary IncontinenceObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172614000Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, LeftCaldera Medical, Inc.2018-05-04PWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00890594000933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00890594000933008905940009338905940009330890594000933

GMDN Terms#

Term, Definition table
TermDefinition
Transobturator needle, reusableA hand-held manual surgical instrument with a sharp pyramidal or conical point intended to be used to create a percutaneous puncture using the transobturator approach (i.e., insertion points overlie the obturator space and the obturator foramen membrane is penetrated), for the surgical positioning of a sling used in the treatment of stress urinary incontinence (SUI), which may be associated with a prolapse. The distal working end is typically made of a stainless steel rod that is markedly curved or helicoidal (right- or left-angled), with a pointed tip and an eye or notch to help position the sling. The device can be made of metal and/or polymer materials. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store wrapped instruments in a designated sterile supply area that protects sterile items and their packaging from damage. This area should be clean, dry and free of contaminants.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization
Moist Heat or Steam Sterilization

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
true
Lot or batch
true
Sterilization required before use
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
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.PWJ2022-08-03
00890594000131Desara TVez 2.7Caldera Medical, Inc.PWJ2022-08-03
00890594000155Desara TVez 3.0Caldera Medical, Inc.PWJ2022-08-03
00890594000193Desara Blue TVez 2.7Caldera Medical, Inc.PWJ2022-08-03
00890594000087Desara Blue TVez 3.0Caldera Medical, Inc.PWJ2021-11-15
00890594000094Desara Blue TVez 2.7Caldera Medical, Inc.PWJ2021-11-15
00890594000100Desara TVez 2.7Caldera Medical, Inc.PWJ2021-11-15
00890594000117Desara TVez 3.0Caldera Medical, Inc.PWJ2021-11-15
00890594000957Desara One Caldera Medical, Inc.PWJ2020-02-25
00890594000971Desara One Caldera Medical, Inc.PWJ2020-02-25
00890594000940Transobturator Inside-Out, Left 3.2 mm IntroducerCaldera Medical, Inc.PWJ2019-11-05
00890594000018Transobturator Helical, Left IntroducerCaldera Medical, Inc.PWJ2019-09-30
00890594000148Transobturator Helical, Right IntroducerCaldera Medical, Inc.PWJ2019-09-30
00890594000162Transobturator Large Helical, Left IntroducerCaldera Medical, Inc.PWJ2019-09-30
00890594000179Transobturator Large Helical, Right IntroducerCaldera Medical, Inc.PWJ2019-09-30
00890594000186Transobturator Inside-Out, Left IntroducerCaldera Medical, Inc.PWJ2019-09-30
00890594000209Transobturator Inside-Out, Right IntroducerCaldera Medical, Inc.PWJ2019-09-30
00890594000216Transobturator Hook IntroducerCaldera Medical, Inc.PWJ2019-09-30
00890594000223Suprapubic IntroducerCaldera Medical, Inc.PWJ2019-09-30
00890594000230Transvaginal 4.0 mm IntroducerCaldera Medical, Inc.PWJ2019-09-30
00890594000278Winged Guide AccessoryCaldera Medical, Inc.PWJ2019-09-30
00890594000865Transvaginal 3.2 mm IntroducerCaldera Medical, Inc.PWJ2019-09-30