L Hook for Bovie Pencil Handle - L Hook for Bovie Pencil Handle - ORANGE SURGICAL INSTRUMENTS, LLC

Duns Number:047063695

Device Description: L Hook for Bovie Pencil Handle

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More Product Details

Catalog Number

OS-L-Hook-44-5-B

Brand Name

L Hook for Bovie Pencil Handle

Version/Model Number

OS-L-Hook-44-5-B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 14, 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

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

af36c5eb-7ba4-4089-9c6f-f7cf00115b08

Public Version Date

November 14, 2019

Public Version Number

3

DI Record Publish Date

November 14, 2016

Additional Identifiers

Package DI Number

B354OSLHOOK445B10

Quantity per Package

10

Contains DI Package

B354OSLHOOK445B0

Package Discontinue Date

November 14, 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