Catalog Number

C-SHIELD-1.0

Brand Name

HaloShield

Version/Model Number

G46289

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K905766,K905766

Product Code

GBX

Product Code Name

CATHETER, IRRIGATION

Public Device Record Key

373f8ad4-9fd2-4cf9-b9f7-93b5d11bd8e2

Public Version Date

March 19, 2019

Public Version Number

1

DI Record Publish Date

March 11, 2019

Package DI Number

10827002462899

Quantity per Package

5

Contains DI Package

00827002462892

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-