Duns Number:118744421
Device Description: Antimicrobial Super Sponge 4.5X4.1 Yards-6P,EO
Catalog Number
SP001
Brand Name
CALICO
Version/Model Number
SP001
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
K181315,K181315
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
0116926e-e0cf-404f-88c1-2f4f2a09210d
Public Version Date
August 30, 2022
Public Version Number
1
DI Record Publish Date
August 22, 2022
Package DI Number
10850044458674
Quantity per Package
100
Contains DI Package
00850044458677
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |