Duns Number:008162518
Device Description: Instrument Container; Mini; Single-Use Paper Filters w/out steam indicators; 235x118mm; wh Instrument Container; Mini; Single-Use Paper Filters w/out steam indicators; 235x118mm; white
Catalog Number
gS 98.9900
Brand Name
gSource
Version/Model Number
gS 98.9900
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123234
Product Code
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
d285b84e-0444-4ec8-a61b-a1e39ad69cff
Public Version Date
June 06, 2022
Public Version Number
1
DI Record Publish Date
May 27, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4617 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 280 |