Duns Number:081253414
Device Description: Universal Table Pad Cover
Catalog Number
-
Brand Name
Domico Med-Device
Version/Model Number
9121
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BWN
Product Code Name
Table And Attachments, Operating-Room
Public Device Record Key
6514d631-c67f-47e0-ab80-4f175f7e38ca
Public Version Date
December 27, 2019
Public Version Number
1
DI Record Publish Date
December 19, 2019
Package DI Number
10861001002656
Quantity per Package
4
Contains DI Package
00861001002659
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 512 |
2 | A medical device with a moderate to high risk that requires special controls. | 35 |