Surgimedics® - Fiber Optic Cable, Single-Use Disposable - COASTAL LIFE TECHNOLOGIES, INC.

Duns Number:809254670

Device Description: Fiber Optic Cable, Single-Use Disposable

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Surgimedics®

Version/Model Number

9S-6075

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)

-

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

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

c9feda98-039d-4227-b8b8-e3ecadc627ce

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10814716020477

Quantity per Package

5

Contains DI Package

00814716020470

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"COASTAL LIFE TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 41