Catalog Number

-

Brand Name

Egress Cannula

Version/Model Number

2100-575A

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"

Yes

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

K092544

Product Code

DXC

Product Code Name

CLAMP, VASCULAR

Public Device Record Key

a4bf20c3-7ad7-4dfb-aaef-6596f33ba76a

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

July 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-