Duns Number:243730939
Device Description: SPY2000 drug and drape kit
Catalog Number
SK6000
Brand Name
SPY
Version/Model Number
SK6000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 20, 2021
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
-
Product Code
IZI
Product Code Name
System, x-ray, angiographic
Public Device Record Key
be3abd73-bff6-4313-ab5f-63d0f229a02c
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
September 21, 2020
Package DI Number
20858701006210
Quantity per Package
6
Contains DI Package
10858701006213
Package Discontinue Date
June 20, 2021
Package Status
Not in Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |
| 3 | A medical device with high risk that requires premarket approval | 1 |