Catalog Number

-

Brand Name

E.M Adams co, inc.

Version/Model Number

14-70845-1

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

K812132,K812132

Product Code

MCZ

Product Code Name

Suture Removal Kit

Public Device Record Key

1e1ddb77-d48f-451d-879e-680bd9fa7a0a

Public Version Date

May 31, 2021

Public Version Number

1

DI Record Publish Date

May 21, 2021

Package DI Number

50840200302871

Quantity per Package

200

Contains DI Package

10840200302880

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case