Synergetics - "The Lumenator™" Spetzler™-Malis® Disposable - SYNERGETICS USA, INC.

Duns Number:021056726

Device Description: "The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 8", 0.5mm T "The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 8", 0.5mm Tip, Insulated, Non-Stick

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More Product Details

Catalog Number

DSYN-LB80-05I

Brand Name

Synergetics

Version/Model Number

DSYN-LB80-05I

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)

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

af9221ba-ebe8-4f1a-99c1-63a5c0c6c3cc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNERGETICS USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 336
2 A medical device with a moderate to high risk that requires special controls. 47