Soft Tissue Sleeve - A hand-held stainless steel tube used during a - Curvafix Inc

Duns Number:039779098

Device Description: A hand-held stainless steel tube used during a CurvaFix procedure to maintain direct acces A hand-held stainless steel tube used during a CurvaFix procedure to maintain direct access to the surgical site, protect the patient soft tissue, and facilitate the acceptance of other orthopaedic instrumentation into the surgical site.

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More Product Details

Catalog Number

CTS-001

Brand Name

Soft Tissue Sleeve

Version/Model Number

CTS-001

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

-

Product Code Details

Product Code

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Device Record Status

Public Device Record Key

22589f14-1a72-430a-a0be-295185d48b9e

Public Version Date

June 28, 2022

Public Version Number

1

DI Record Publish Date

June 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CURVAFIX INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 51