Monopolar Grasper Atraumatic, 5mm x 33cm, Reusable - Monopolar Grasper Atraumatic, 5mm x 33cm, Reusable - ORANGE SURGICAL INSTRUMENTS, LLC

Duns Number:047063695

Device Description: Monopolar Grasper Atraumatic, 5mm x 33cm, Reusable

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More Product Details

Catalog Number

OS-33-3-RMG

Brand Name

Monopolar Grasper Atraumatic, 5mm x 33cm, Reusable

Version/Model Number

OS-33-3-RMG

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 2019

Issuing Agency

In HIBCC

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

03f4c377-dbb5-4c4d-9d58-f69133252e18

Public Version Date

November 15, 2019

Public Version Number

3

DI Record Publish Date

November 15, 2016

Additional Identifiers

Package DI Number

B354OS333RMG10

Quantity per Package

10

Contains DI Package

B354OS333RMG0

Package Discontinue Date

November 15, 2019

Package Status

Not in Commercial Distribution

Package Type

-

"ORANGE SURGICAL INSTRUMENTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 271