Catalog Number

-

Brand Name

Cottle Mucosa Knife

Version/Model Number

412-559

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

EMF

Product Code Name

KNIFE, SURGICAL

Public Device Record Key

57e79dbb-81fe-4bb1-addd-e5a6d35d465d

Public Version Date

September 23, 2022

Public Version Number

1

DI Record Publish Date

September 15, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-