Constrictor® Rope - Knotless Syndesmosis Repair Kit - DUNAMIS MEDICAL, LLC

Duns Number:079471560

Device Description: Knotless Syndesmosis Repair Kit

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More Product Details

Catalog Number

DLF 002

Brand Name

Constrictor® Rope

Version/Model Number

DLF 002

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"

Yes

For Single-Use

Yes

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

HTN

Product Code Name

Washer, Bolt Nut

Device Record Status

Public Device Record Key

d9452997-2323-497f-9b78-4fea9fe012bc

Public Version Date

December 29, 2021

Public Version Number

1

DI Record Publish Date

December 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DUNAMIS MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 43