Catalog Number

E4-4208P, 4-4208P

Brand Name

AMT Bridle Pro®

Version/Model Number

E4-4208P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K030784,K142971,K030784,K142971

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

388e17a3-8d81-4f0d-b417-09cfe4f7a244

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 17, 2021

Package DI Number

00842071131098

Quantity per Package

5

Contains DI Package

00842071131067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box 5