Catalog Number

-

Brand Name

Americot

Version/Model Number

20-28S

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K854713,K854713

Product Code

HBA

Product Code Name

Neurosurgical Paddie

Public Device Record Key

fe7fa713-46fe-46e5-8de0-92fa86f1e018

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-