Catalog Number

92-35

Brand Name

Scleral Buckling Products: Style N/A, 2.5mm Oval Silicone Sleeve

Version/Model Number

92-35

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

K023481,K023481

Product Code

HQX

Product Code Name

Implant, Orbital, Extra-Ocular

Public Device Record Key

d9f04ff7-0d18-40da-a443-e8f7cb8b6f52

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2015

Package DI Number

18717872014538

Quantity per Package

5

Contains DI Package

08717872014531

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box