Duns Number:058614483
Device Description: ENDO CATHETER EF-322N 16CM NASAL TIP
Catalog Number
-
Brand Name
EndoFLIP
Version/Model Number
EF-322N
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
K183072,K183072
Product Code
FFX
Product Code Name
SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
Public Device Record Key
fff0212d-abdc-48d6-a3fb-fe3826e5d727
Public Version Date
April 05, 2022
Public Version Number
3
DI Record Publish Date
March 15, 2021
Package DI Number
20884521809410
Quantity per Package
5
Contains DI Package
10884521809413
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |