Duns Number:014464314
Device Description: Dual Layer Sterile Stretcher/Trolley Mat - Med Mad 2500
Catalog Number
6077D
Brand Name
MedMat
Version/Model Number
6077D
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101598,K101598,K101598
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
1a263bf5-88a8-49e8-8cba-d68658a081de
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
January 16, 2019
Package DI Number
00850003355245
Quantity per Package
2
Contains DI Package
10850003355235
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 489 |