HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5710 BLADE - QTY 24 - HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5710 - HEMOSTATIX MEDICAL TECHNOLOGIES LLC

Duns Number:791221265

Device Description: HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5710 BLADE - QTY 24

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More Product Details

Catalog Number

7013-5710

Brand Name

HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5710 BLADE - QTY 24

Version/Model Number

7013-5710

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

K033089,K033089

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

1b9c47eb-2c0b-473f-9bf2-bfc96790e930

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEMOSTATIX MEDICAL TECHNOLOGIES LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5