Duns Number:631770658
Device Description: Mepitel One 5x7,5 cm, FR ph
Catalog Number
-
Brand Name
Mepitel® One
Version/Model Number
289100
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
-
Product Code
NAD
Product Code Name
Dressing, wound, occlusive
Public Device Record Key
01d50da2-eeb8-411e-82bb-c13e4aff3876
Public Version Date
October 31, 2022
Public Version Number
1
DI Record Publish Date
October 21, 2022
Package DI Number
07323190232161
Quantity per Package
10
Contains DI Package
07332551023720
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 212 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| U | Unclassified | 18 |