25ga Endo-Ocular Probes Steerable, Iridex Compatible - Box of 10, 25ga Endo-Ocular Probes Steerable, - KATALYST SURGICAL LLC

Duns Number:007883297

Device Description: Box of 10, 25ga Endo-Ocular Probes Steerable, Iridex Compatible

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More Product Details

Catalog Number

-

Brand Name

25ga Endo-Ocular Probes Steerable, Iridex Compatible

Version/Model Number

XLEND25DIRA

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

Product Code Details

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Device Record Status

Public Device Record Key

e87c5181-76ad-4f4e-bacc-c537cd6d2dab

Public Version Date

May 07, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

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