Duns Number:869434464
Device Description: 500 ML, USP STERILE WATER, BOTTLE
Catalog Number
-
Brand Name
SteriCare Solutions
Version/Model Number
6290
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
K083042,K083042
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
4b49b8ea-f09e-4252-8a9f-20b13f789308
Public Version Date
September 10, 2021
Public Version Number
1
DI Record Publish Date
September 02, 2021
Package DI Number
10850421008782
Quantity per Package
18
Contains DI Package
00850421008785
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 7 |