Duns Number:047571476
Device Description: Inflation Device Atrion Part Number 96378A: 60mL, 15atm
Catalog Number
CID-60-15
Brand Name
Sphere™ Inflation Device
Version/Model Number
QL6015
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KOE
Product Code Name
Dilator, Urethral
Public Device Record Key
1db71063-138e-4b8e-9a99-3565c033095c
Public Version Date
January 08, 2021
Public Version Number
6
DI Record Publish Date
September 21, 2016
Package DI Number
10827002349039
Quantity per Package
1
Contains DI Package
00827002349032
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 61 |