Duns Number:025460908
Device Description: DRESSING,MAXORB EXTRA AG,SILVER ALG,8X12
Catalog Number
MSC94812EP
Brand Name
Medline
Version/Model Number
MSC94812EP
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
Yes
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
f936e4b9-64ef-4a57-959c-3481d5dad395
Public Version Date
October 28, 2021
Public Version Number
1
DI Record Publish Date
October 20, 2021
Package DI Number
40080196323174
Quantity per Package
50
Contains DI Package
30080196323177
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 | 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 |