Duns Number:315731430
Device Description: Suction Tube, curved 8 mm, Ø 1.2 mm
Catalog Number
-
Brand Name
n.a.
Version/Model Number
204365C
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K945237
Product Code
EOX
Product Code Name
Esophagoscope (flexible or rigid)
Public Device Record Key
98b270a1-45f9-4ac1-9bf6-ef793b03218a
Public Version Date
April 20, 2020
Public Version Number
2
DI Record Publish Date
March 13, 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 | 3584 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4864 |
| 3 | A medical device with high risk that requires premarket approval | 18 |