Duns Number:315304071
Device Description: SUCT./IRRIG. TUBE OD 6.2MM WL 128MM for use with suction-irrigation handle 8475.26 and te SUCT./IRRIG. TUBE OD 6.2MM WL 128MM for use with suction-irrigation handle 8475.26 and telescopes 8880.541 and 8880.543, straight, reusable
Catalog Number
8475.031
Brand Name
NA
Version/Model Number
8475031
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EOB
Product Code Name
NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
Public Device Record Key
be56e59f-4f95-4509-8d5c-c75e1b91ce2f
Public Version Date
March 11, 2019
Public Version Number
6
DI Record Publish Date
September 28, 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 | 587 |
2 | A medical device with a moderate to high risk that requires special controls. | 1835 |