Duns Number:014464314
Device Description: Dual Layer Sterile Procedure Mat - Med Mat 1100
Catalog Number
6075D
Brand Name
MedMat
Version/Model Number
6075D
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
4a41d8d6-ab93-4289-bfa1-5baf72455df4
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
January 16, 2019
Package DI Number
00850003355191
Quantity per Package
4
Contains DI Package
00850003355184
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 |