Caldera Medical, Inc.

Address:4360 Park Terrace Drive,Westlake Village,CA,91361,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence (PWJ) (8) Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (OTO) (2) Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (OTN) (1)

Premarket Exempt

Clear

Transobturator Large Helical, Right Introducer - 00890594000179 Catalog Number : CAL-LHR2

Device Description : Transobturator Large Helical, Right Introducer is a surgical mesh instrument to Transobturator Large Helical, Right Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh.

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : PWJ

Prescription Use : Yes

Device Count : 1

Transobturator Inside-Out, Left Introducer - 00890594000186 Catalog Number : CAL-IO6

Device Description : Transobturator Inside-Out, Left Introducer is a surgical mesh instrument to be u Transobturator Inside-Out, Left Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh.

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : PWJ

Prescription Use : Yes

Device Count : 1

Desara Blue TVez 2.7 - 00890594000193 Catalog Number :

Device Description : Desara Blue TVez 2.7mm for the treatment of female stress urinary incontinence ( Desara Blue TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTN, PWJ

Prescription Use : Yes

Device Count : 1

Transobturator Inside-Out, Right Introducer - 00890594000209 Catalog Number : CAL-IO7

Device Description : Transobturator Inside-Out, Right Introducer is a surgical mesh instrument to be Transobturator Inside-Out, Right Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh.

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : PWJ

Prescription Use : Yes

Device Count : 1

Transobturator Hook Introducer - 00890594000216 Catalog Number : CAL-TB03

Device Description : Transobturator Hook Introducer is a surgical mesh instrument to be used in surgi Transobturator Hook Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh.

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : PWJ

Prescription Use : Yes

Device Count : 1

Suprapubic Introducer - 00890594000223 Catalog Number : CAL-SP01

Device Description : Suprapubic Introducer is a surgical mesh instrument to be used in surgical proce Suprapubic Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh.

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : PWJ

Prescription Use : Yes

Device Count : 1

Transvaginal 4.0 mm Introducer - 00890594000230 Catalog Number : CAL-TV02

Device Description : Transvaginal 4.0 mm Introducer is a surgical mesh instrument to be used in surgi Transvaginal 4.0 mm Introducer is a surgical mesh instrument to be used in surgical procedures for the insertion and placement of Desara surgical mesh.

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : PWJ

Prescription Use : Yes

Device Count : 1

Winged Guide Accessory - 00890594000278 Catalog Number : CAL-WI

Device Description : The Winged Guide Accessory may be referred to as the winged guide or guide and i The Winged Guide Accessory may be referred to as the winged guide or guide and is for use with the Caldera Medical Inside-Out introducers only.

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : PWJ

Prescription Use : Yes

Device Count : 1

Vertessa Lite 10x22cm - 00890594000339 Catalog Number :

Device Description : Vertessa Lite 10x22cm polypropylene mesh for sacrocolpopexy

Device Class :

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTO

Prescription Use : Yes

Device Count : 1

Vertessa Lite 10x26cm - 00890594000360 Catalog Number :

Device Description : Vertessa Lite 10x26cm polypropylene mesh for sacrocolpopexy

Device Class :

Duns Number: 130341956

Premarket Exempt : No

Product Code : OTO

Prescription Use : Yes

Device Count : 1

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