MUELLER CTTAPE CARPAL TUNNEL TAPE - CTTAPE CARPAL TUNNEL TAPE 3APP - Mueller Sports Medicine, Inc.

Duns Number:006426316

Device Description: CTTAPE CARPAL TUNNEL TAPE 3APP

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More Product Details

Catalog Number

6437

Brand Name

MUELLER CTTAPE CARPAL TUNNEL TAPE

Version/Model Number

6437

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FQM

Product Code Name

BANDAGE, ELASTIC

Device Record Status

Public Device Record Key

de208a55-a476-40a9-bac1-6f8658b95a3d

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 15, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MUELLER SPORTS MEDICINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 148
2 A medical device with a moderate to high risk that requires special controls. 15