Catalog Number

-

Brand Name

AUTOSTABLE BICANALICULUS INTUBATION SET II (30 MM) WITH DILATOR

Version/Model Number

S1.1391

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

-

Product Code

OKS

Product Code Name

Lacrimal Stents And Intubation Sets

Public Device Record Key

f67ea81f-52d7-4a44-9746-442831294c13

Public Version Date

June 07, 2021

Public Version Number

1

DI Record Publish Date

May 30, 2021

Package DI Number

13760087120339

Quantity per Package

1

Contains DI Package

03760087120332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-