Bioseal Inc. - Vaginal Speculum Clear Medium, Light Source - BIOSEAL

Duns Number:186968939

Device Description: Vaginal Speculum Clear Medium, Light Source

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More Product Details

Catalog Number

-

Brand Name

Bioseal Inc.

Version/Model Number

KI805/20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HIC

Product Code Name

Speculum, vaginal, nonmetal, fiberoptic

Device Record Status

Public Device Record Key

18a90752-fb9a-48d3-94e8-b8c75ff31817

Public Version Date

February 05, 2020

Public Version Number

1

DI Record Publish Date

January 28, 2020

Additional Identifiers

Package DI Number

10630094298051

Quantity per Package

20

Contains DI Package

00630094298054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"BIOSEAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 86