Duns Number:021717889
Device Description: Inflation Device
Catalog Number
-
Brand Name
Encore 26
Version/Model Number
M0067101140
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
PTM
Product Code Name
Syringe, Balloon Inflation, Exempt
Public Device Record Key
10cf8e1d-1145-44bd-ba24-a8b149e7ab0a
Public Version Date
May 06, 2020
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
08714729761815
Quantity per Package
5
Contains DI Package
08714729755814
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |