Duns Number:007198742
Device Description: "70230912 AUTOCLAVABLE SCOPE 4MM 70 DEGR"
Catalog Number
-
Brand Name
RIGID SINUSCOPE 4 MM, 70 DEGREES AUTOCLAVABLE
Version/Model Number
70230912
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
K874215
Product Code
EOB
Product Code Name
NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
Public Device Record Key
a1e78676-63f0-4f8a-a8e5-25b38e2b5c0d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 12, 2016
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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |