Duns Number:600634887
Device Description: Package of 30 SU-VEID units (DI# 07290018896037)
Catalog Number
18103200
Brand Name
SU-VEID
Version/Model Number
18103200
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
K993995
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
56c6d7ba-fb2f-41c9-ac0c-1f83aa396620
Public Version Date
May 31, 2021
Public Version Number
1
DI Record Publish Date
May 23, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 3 |