Transobturator Helical, Left Introducer - Transobturator Helical, 3.2mm, Left Introducer is - Caldera Medical, Inc.

Duns Number:130341956

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

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More Product Details

Catalog Number

CAL-HL32

Brand Name

Transobturator Helical, Left Introducer

Version/Model Number

CAL-HL32

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

e1fa1225-f6a0-42aa-bc09-233de25ca8fa

Public Version Date

August 11, 2022

Public Version Number

1

DI Record Publish Date

August 03, 2022

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