Single Use Biopsy Forceps - OLYMPUS MEDICAL SYSTEMS CORP.

Duns Number:711789789

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More Product Details

Catalog Number

-

Brand Name

Single Use Biopsy Forceps

Version/Model Number

FB-215U

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

FCL

Product Code Name

Forceps, Biopsy, Non-Electric

Device Record Status

Public Device Record Key

d279bb34-684b-40c6-b9c0-300e5325215f

Public Version Date

December 27, 2021

Public Version Number

1

DI Record Publish Date

December 17, 2021

Additional Identifiers

Package DI Number

14953170398831

Quantity per Package

20

Contains DI Package

04953170398834

Package Discontinue Date

-

Package Status

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