Catalog Number

-

Brand Name

ZeroWire G2

Version/Model Number

90T2112

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 27, 2022

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

da550cf2-07ce-40ec-8f72-39e986959bb2

Public Version Date

April 04, 2022

Public Version Number

1

DI Record Publish Date

March 27, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-