Catalog Number

-

Brand Name

α-spot

Version/Model Number

W201

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

-

Product Code

JKA

Product Code Name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Public Device Record Key

d8ff873c-715a-43f4-a14b-3326bfac911e

Public Version Date

August 16, 2021

Public Version Number

1

DI Record Publish Date

August 06, 2021

Package DI Number

10860802000397

Quantity per Package

7200

Contains DI Package

00860802000390

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-