Dynamic Tissue Systems™ - Southmedic Surgical Retainer Small - Southmedic Incorporated

Duns Number:246848147

Device Description: Southmedic Surgical Retainer Small

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More Product Details

Catalog Number

CWKSR-S

Brand Name

Dynamic Tissue Systems™

Version/Model Number

CWKSR-S

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

GZC

Product Code Name

Stimulator, neuromuscular, implanted

Device Record Status

Public Device Record Key

343049c3-7b7a-415b-a38d-40cd2f6e8cc4

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 18, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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