Moby® - Green Moby® Jointed Cutter Assembly - Stanley Medical Designs, Incorporated

Duns Number:087844537

Device Description: Green Moby® Jointed Cutter Assembly

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More Product Details

Catalog Number

1510-01

Brand Name

Moby®

Version/Model Number

1510-01

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

FZT

Product Code Name

Cutter, Surgical

Device Record Status

Public Device Record Key

af6c78bf-03f3-40d8-b5ca-0992727cc957

Public Version Date

March 07, 2022

Public Version Number

1

DI Record Publish Date

February 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STANLEY MEDICAL DESIGNS, INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11