Catalog Number

-

Brand Name

Antmed

Version/Model Number

ID1221

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

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

K102648,K102648,K102648

Product Code

MAV

Product Code Name

Syringe, Balloon Inflation

Public Device Record Key

ea41606f-c4e2-4d08-9e4d-50a4d4195bb9

Public Version Date

October 31, 2018

Public Version Number

4

DI Record Publish Date

August 24, 2017

Package DI Number

06945764414042

Quantity per Package

5

Contains DI Package

06945764414011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-