Duns Number:076916246
Device Description: Aquatec Ocean Splash Guard
Catalog Number
AP1603155
Brand Name
Aquatec Ocean Splash Guard
Version/Model Number
AP1603155
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
INN
Product Code Name
CHAIR, ADJUSTABLE, MECHANICAL
Public Device Record Key
1183731f-f6a2-4e27-8c3e-236e45e971ef
Public Version Date
October 29, 2019
Public Version Number
1
DI Record Publish Date
October 21, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 136 |
2 | A medical device with a moderate to high risk that requires special controls. | 273 |