Catalog Number

-

Brand Name

Integra SP VS02

Version/Model Number

00101T2

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K061102

Product Code

BSZ

Product Code Name

Gas-Machine, Anesthesia

Public Device Record Key

cabaa2bc-219b-45f6-887f-d4d0e61a558c

Public Version Date

March 29, 2021

Public Version Number

4

DI Record Publish Date

December 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-