Duns Number:056038268
Device Description: Headband Memory Foam Pads
Catalog Number
00-9900-004-00
Brand Name
TOTALSHIELD®
Version/Model Number
00-9900-004-00
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYA
Product Code Name
GOWN, SURGICAL
Public Device Record Key
5222f767-5b86-4abd-9779-1ff63f050b3c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 07, 2017
Package DI Number
00889024380349
Quantity per Package
8
Contains DI Package
00889024376267
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8464 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20880 |
| 3 | A medical device with high risk that requires premarket approval | 133 |