Duns Number:256880576
Device Description: SAFESEAL QUATTRO 3 1/2" X 9" SELF-SEALING STERILIZATION POUCHES
Catalog Number
88010-4B
Brand Name
MEDICOM SAFESEAL QUATTRO
Version/Model Number
88010-4B
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
b92f36a6-340f-4800-82e7-8860fb4bb162
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
February 27, 2018
Package DI Number
20686864045742
Quantity per Package
3000
Contains DI Package
10686864045745
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |