Duns Number:182052670
Device Description: 260I 30X30,250
Catalog Number
1010260I3030
Brand Name
STERIMED, Inc.
Version/Model Number
1010260I3030
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
K931202
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
1e3c8e69-2605-48a6-af73-db55ee4a311a
Public Version Date
January 04, 2021
Public Version Number
3
DI Record Publish Date
April 01, 2018
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. | 105 |