L Hook nonstick for ESU Pencil - L Hook nonstick for ESU Pencil - ORANGE SURGICAL INSTRUMENTS, LLC

Duns Number:047063695

Device Description: L Hook nonstick for ESU Pencil

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More Product Details

Catalog Number

OSLHOOK335P

Brand Name

L Hook nonstick for ESU Pencil

Version/Model Number

OSLHOOK335P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

807ecb78-657d-4d60-9560-1565220d597e

Public Version Date

August 17, 2021

Public Version Number

2

DI Record Publish Date

January 11, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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