Catalog Number

SDRB-REG-LT/B

Brand Name

PreludeSYNC DISTAL™

Version/Model Number

10884450574413

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DXC

Product Code Name

CLAMP, VASCULAR

Public Device Record Key

4076dc9f-853b-4663-965e-3237add2580c

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 21, 2022

Package DI Number

20884450574410

Quantity per Package

4

Contains DI Package

10884450574413

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-