Duns Number:025460908
Device Description: DRESSING, CAL ALG,MAXORB AG ES,.75"X18"
Catalog Number
MSC1918EP
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
MSC1918EP
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"
Yes
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
K070581,K070581,K070581
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
acdb2fde-6d65-4f1e-a311-b618251755ea
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
May 18, 2021
Package DI Number
30884389811287
Quantity per Package
5
Contains DI Package
10884389811283
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |