Duns Number:014464314
Device Description: Dual Layer Sterile Procedure Bed Mat - Med Mat 3000
Catalog Number
6076D
Brand Name
Medmat
Version/Model Number
6076D
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
d0143742-28bc-419c-9460-ac310593b0d7
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
January 16, 2019
Package DI Number
00850003355221
Quantity per Package
2
Contains DI Package
00850003355214
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 |