Catalog Number

99109

Brand Name

Modified Ham's F-10 with Albumin

Version/Model Number

99109-100ML

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

Yes

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

-

FDA Premarket Submission

K991420

Product Code

HDR

Product Code Name

Cap, Cervical

Public Device Record Key

4ddbd605-41dd-4050-b0d1-e84b3ae19b9a

Public Version Date

February 13, 2019

Public Version Number

4

DI Record Publish Date

September 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-