Catalog Number

-

Brand Name

eClear

Version/Model Number

HTD2601US

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

20e7b90f-6fa2-495d-a8b4-f93d1197b534

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 06, 2021

Package DI Number

16970289035400

Quantity per Package

60

Contains DI Package

06970289035403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-