Catalog Number

1305-014

Brand Name

Peelaway Introducer Sheath, 14Fr

Version/Model Number

1305-014

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"

-

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

K200925

Product Code

GWG

Product Code Name

Endoscope, Neurological

Public Device Record Key

6088df92-1052-4dfc-b7c4-9484b54c7d08

Public Version Date

May 05, 2021

Public Version Number

1

DI Record Publish Date

April 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-