Duns Number:835233107
Device Description: STARSHIELD 9734470 DISP FLOOR FOIL 5PK
Catalog Number
-
Brand Name
N/A
Version/Model Number
9734470
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
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
K032541,K032541
Product Code
LNH
Product Code Name
System, nuclear magnetic resonance imaging
Public Device Record Key
90928355-2462-4fec-adfa-7b4e64f2a437
Public Version Date
September 20, 2021
Public Version Number
6
DI Record Publish Date
June 18, 2016
Package DI Number
20613994728535
Quantity per Package
5
Contains DI Package
00613994728531
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1961 |
| 3 | A medical device with high risk that requires premarket approval | 1 |