Duns Number:057728685
Device Description: Nylon Sterilization Tubing, 6 in (15.2 cm)100 ft (30 m) Roll
Catalog Number
-
Brand Name
Sani-Tube™ Nylon Sterilization Tubing, without process indicators
Version/Model Number
SN6
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)
-
Over the Counter (OTC)
-
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
9cb2f218-ca90-4c71-bfb6-20790ad0a4a4
Public Version Date
May 11, 2022
Public Version Number
1
DI Record Publish Date
May 03, 2022
Package DI Number
50732224110252
Quantity per Package
12
Contains DI Package
10732224110254
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |