Catalog Number

7625.DORC

Brand Name

Illuminated Curved Laser probe, 25 gauge / 0,5mm with DORC® connector

Version/Model Number

7625.DORC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K132614,K132614

Product Code

HQB

Product Code Name

Photocoagulator And Accessories

Public Device Record Key

90fac89a-a658-44c6-af5b-badabf191e5c

Public Version Date

March 12, 2019

Public Version Number

1

DI Record Publish Date

March 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-