Catalog Number

11-15750

Brand Name

Aztec

Version/Model Number

11-15750

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FHQ

Product Code Name

Holder, Needle, Gastroenterologic

Public Device Record Key

3c5e388b-c07f-48ce-91e7-b5fb4dc7cdd0

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

October 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-