Catalog Number

-

Brand Name

Fastlock

Version/Model Number

PC175M04

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

K080621,K080621

Product Code

DSA

Product Code Name

CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Public Device Record Key

13e6499b-9a5a-4535-9d37-6ee26429e2c2

Public Version Date

February 04, 2019

Public Version Number

6

DI Record Publish Date

October 04, 2016

Package DI Number

08718627410707

Quantity per Package

10

Contains DI Package

08718627410691

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-