Catalog Number

-

Brand Name

Celt ACD Vascular Closure Device 6F

Version/Model Number

KCLT-06

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

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

P150006,P150006,P150006

Product Code

MGB

Product Code Name

Device, Hemostasis, Vascular

Public Device Record Key

7c455681-c2e4-4b60-a32b-315eec0169ce

Public Version Date

October 21, 2020

Public Version Number

4

DI Record Publish Date

July 21, 2017

Package DI Number

05391530280075

Quantity per Package

5

Contains DI Package

05391530280068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton