Catalog Number

-

Brand Name

Silicone Tire 6.0mm

Version/Model Number

S 2994

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K875014,K875014

Product Code

HQJ

Product Code Name

Implant, Absorbable, (Scleral Buckling Methods)

Public Device Record Key

28a1a810-8380-4bea-8fd1-b7eeb7105567

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

October 09, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-