Catalog Number

0004512

Brand Name

Alpha-Tec Systems

Version/Model Number

0

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K881698

Product Code

JCC

Product Code Name

Ph Buffer

Public Device Record Key

a211f98a-745d-4bad-ade6-7b4efd671561

Public Version Date

August 18, 2022

Public Version Number

1

DI Record Publish Date

August 10, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-