Duns Number:790514756
Device Description: STARBoard Drape, includes 1 each 12" Tape and 1 each 24" Tape
Catalog Number
MRG100
Brand Name
Medical Resources Group Limited
Version/Model Number
MRG100
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
-
Product Code
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
51ba80e2-560e-49d0-a234-e638e5c9f35a
Public Version Date
October 05, 2021
Public Version Number
1
DI Record Publish Date
September 27, 2021
Package DI Number
10815384020677
Quantity per Package
50
Contains DI Package
00815384020670
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 123 |