DISPOSABLE GRASPING FORCEPS - OLYMPUS MEDICAL SYSTEMS CORP.

Duns Number:711789789

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

DISPOSABLE GRASPING FORCEPS

Version/Model Number

FG-55D

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 27, 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

K912120,K912120

Product Code Details

Product Code

FBN

Product Code Name

Choledochoscope and accessories, flexible/rigid

Device Record Status

Public Device Record Key

c855133e-5187-4e65-94ec-829c77bc33ed

Public Version Date

June 28, 2022

Public Version Number

6

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

14953170375078

Quantity per Package

1

Contains DI Package

04953170375071

Package Discontinue Date

June 27, 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