Catalog Number

-

Brand Name

Bioseal Inc.

Version/Model Number

KI101S/20

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

-

Product Code

HIB

Product Code Name

Speculum, vaginal, nonmetal

Public Device Record Key

2f29a752-523c-4a95-8761-b4c9380fa9f8

Public Version Date

February 05, 2020

Public Version Number

1

DI Record Publish Date

January 28, 2020

Package DI Number

10630094910113

Quantity per Package

20

Contains DI Package

00630094410111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case