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

Hysteroscope (And Accessories) (HIH) (5) Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence (PWJ) (3) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (2)

Premarket Exempt

Clear

Transobturator Helical, Left Introducer - 00857492008003 Catalog Number : CAL-HL32

Device Description : Transobturator Helical, 3.2mm, Left Introducer is a surgical mesh instrument to Transobturator Helical, 3.2mm, 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

Transobturator Helical, Right Introducer - 00857492008010 Catalog Number : CAL-HR32

Device Description : Transobturator Helical, 3.2mm, Right Introducer is a surgical mesh instrument to Transobturator Helical, 3.2mm, 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

Benesta Hysteroscope Set - 00857492008041 Catalog Number :

Device Description : Benesta Rod Lens Hysteroscope for viewing of the cervical canal and uterine cavi Benesta Rod Lens Hysteroscope for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative/surgical procedures. The Set contains: CAL-TR113 Benesta Hysteroscope CAL-TR112 Benesta Outflow Channel CAL-TR121 Benesta Hysteroscope Light Source Adapter (Storz/Olympus) CAL-TR122 Benesta Hysteroscope Light Source Adapter (Dyonics/Wolf) CAL-TR123 Benesta Stopcock Lever and Cap (2 each) CAL-TR124 Benesta Hysteroscope/Outflow Channel End Cap (2 each) CAL-TR125 Benesta Working Channel Brush, 3mm CAL-TR126 Benesta Inflow Channel Brush, 2mm

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

Benesta Sterilization Tray - 00857492008065 Catalog Number :

Device Description : The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, The Caldera Medical Benesta Sterilization Tray is intended to enclose, protect, and organize the Caldera Medical Benesta Rod Lens Hysteroscope and accessories during sterilization and storage.

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

Benesta Tissue Removal Device - 00857492008096 Catalog Number :

Device Description : The Benesta Tissue Removal Device is intended for intrauterine use by trained gy The Benesta Tissue Removal Device is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

Benesta Fluid Pack - 00857492008119 Catalog Number :

Device Description : Benesta Fluid Pack for the Benesta Tissue Removal Device. Each pack contains: 1 Benesta Fluid Pack for the Benesta Tissue Removal Device. Each pack contains: 1 single-use Y-Tubing and 2 single-use seals.

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

Benesta Single-Use Seals - 00857492008126 Catalog Number :

Device Description : Benesta Single-Use Seals for Benesta Rod Lens Hysteroscope

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

Benesta Sterilization Tray - 00857492008133 Catalog Number :

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : KCT

Prescription Use : Yes

Device Count : 1

Benesta Hysteroscope Adapter - 00857492008164 Catalog Number :

Device Description : The Benesta Hysteroscope Adapter is placed between non-Caldera Medical hysterosc The Benesta Hysteroscope Adapter is placed between non-Caldera Medical hysteroscopes and the Benesta Tissue Removal Device (TRD) to properly position the TRD while in use.

Device Class : 2

Duns Number: 130341956

Premarket Exempt : No

Product Code : HIH

Prescription Use : Yes

Device Count : 1

Transobturator Helical, Left Introducer - 00890594000018 Catalog Number : CAL-HL04

Device Description : Transobturator Helical, Left Introducer is a surgical mesh instrument to be used Transobturator Helical, 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

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