Dynamic Tissue Systems™ - DynaStretch Set - Southmedic Incorporated

Duns Number:246848147

Device Description: DynaStretch Set

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More Product Details

Catalog Number

DSX38

Brand Name

Dynamic Tissue Systems™

Version/Model Number

DSX38

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

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

MKY

Product Code Name

SYSTEM, SKIN CLOSURE

Device Record Status

Public Device Record Key

fb2a69c8-e491-4fb6-974d-d14f6426e1ea

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 18, 2020

Additional Identifiers

Package DI Number

10620974001758

Quantity per Package

15

Contains DI Package

00620974001751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SOUTHMEDIC INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 91
2 A medical device with a moderate to high risk that requires special controls. 18
3 A medical device with high risk that requires premarket approval 2