DISPOSABLE HOT BIOPSY FORCEPS - DISPOSABLE HOT BIOPSY FORCEPS - OLYMPUS MEDICAL SYSTEMS CORP.

Duns Number:711789789

Device Description: DISPOSABLE HOT BIOPSY FORCEPS

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More Product Details

Catalog Number

-

Brand Name

DISPOSABLE HOT BIOPSY FORCEPS

Version/Model Number

FD-230U

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 09, 2022

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"

Yes

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

-

Product Code Details

Product Code

KGE

Product Code Name

FORCEPS, BIOPSY, ELECTRIC

Device Record Status

Public Device Record Key

10c24e69-06b2-4dfe-9c34-2432b8c940c7

Public Version Date

August 10, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

14953170158763

Quantity per Package

5

Contains DI Package

04953170158766

Package Discontinue Date

August 09, 2022

Package Status

Not in Commercial Distribution

Package Type

-

"OLYMPUS MEDICAL SYSTEMS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 117
2 A medical device with a moderate to high risk that requires special controls. 1962
U Unclassified 52