Catalog Number

090210

Brand Name

LDS-2

Version/Model Number

090210

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 03, 2020

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

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

K905587

Product Code

FZP

Product Code Name

CLIP, IMPLANTABLE

Public Device Record Key

e2d20fed-b7af-454b-869f-35f44a36a49b

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

August 28, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-