Duns Number:120664557
Device Description: SSUmini thread and packaging information
Catalog Number
-
Brand Name
SSUmini thread
Version/Model Number
70-0242
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
-
Product Code
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
d9f6aae8-e548-4c73-8b80-2e5b3c4cd77e
Public Version Date
February 10, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10896241002203
Quantity per Package
24
Contains DI Package
00896241002206
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |