BIPOLAR YASARGIL BAYONET FORCEPS - BIPOLAR YASARGIL BAYONET FORCEPS WITH IRRIGATION - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: BIPOLAR YASARGIL BAYONET FORCEPS WITH IRRIGATION

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More Product Details

Catalog Number

2700-976

Brand Name

BIPOLAR YASARGIL BAYONET FORCEPS

Version/Model Number

2700-976

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

-

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

538e7b3f-6a19-452c-aeae-b0489b61f915

Public Version Date

September 17, 2018

Public Version Number

1

DI Record Publish Date

August 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414