Catalog Number

TEC110B

Brand Name

Cryotec

Version/Model Number

TEC110B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2017

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

K162051,K162051

Product Code

MQK

Product Code Name

Labware, Assisted Reproduction

Public Device Record Key

565da353-a634-436d-8673-8beaa6bdb694

Public Version Date

July 10, 2019

Public Version Number

4

DI Record Publish Date

August 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-