27ga Stiff MultiFlex Inverted Laser Probe, Iridex Connector - 27ga Stiff MultiFlex Inverted Laser Probe, Iridex - KATALYST SURGICAL LLC

Duns Number:007883297

Device Description: 27ga Stiff MultiFlex Inverted Laser Probe, Iridex Connector

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


More Product Details

Catalog Number

-

Brand Name

27ga Stiff MultiFlex Inverted Laser Probe, Iridex Connector

Version/Model Number

V6520-27A

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

K121187,K121187

Product Code Details

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Device Record Status

Public Device Record Key

753017eb-9e7d-460a-8842-aabd99e58b98

Public Version Date

November 04, 2020

Public Version Number

1

DI Record Publish Date

October 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KATALYST SURGICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1640
2 A medical device with a moderate to high risk that requires special controls. 288