Catalog Number

8000SA

Brand Name

Precision

Version/Model Number

8000SA

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMH

Product Code Name

Container, Specimen, Sterile

Public Device Record Key

66cb7952-c8c6-4ebb-9306-b188fbb72246

Public Version Date

February 23, 2021

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

20884527006103

Quantity per Package

50

Contains DI Package

10884527006106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK