Transobturator Helical, Right Introducer - Transobturator Helical, Right Introducer is a - Caldera Medical, Inc.

Duns Number:130341956

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

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More Product Details

Catalog Number

CAL-HR05

Brand Name

Transobturator Helical, Right Introducer

Version/Model Number

CAL-HR05

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172614

Product Code Details

Product Code

PWJ

Product Code Name

Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence

Device Record Status

Public Device Record Key

9196d114-69ac-4d84-99c8-cf7ce1595812

Public Version Date

July 19, 2022

Public Version Number

3

DI Record Publish Date

September 30, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CALDERA MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 31