Catalog Number

96-105-00002

Brand Name

Mergence™-S

Version/Model Number

96-105-00002

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103033

Product Code

HXG

Product Code Name

TAMP

Public Device Record Key

aa0f6b1e-8554-46fa-b4b6-40e626a74702

Public Version Date

June 23, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-