Catalog Number

585010

Brand Name

Visitec®

Version/Model Number

585010

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

K831901,K831901

Product Code

HNL

Product Code Name

Probe, Lachrymal

Public Device Record Key

96331d81-967b-4d9f-9f80-2bba1aa492f8

Public Version Date

November 12, 2021

Public Version Number

2

DI Record Publish Date

November 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-