Duns Number:504406273
Catalog Number
-
Brand Name
BriteBlade Pro Single-Use Fiber Optic Wis-Hipple 1
Version/Model Number
040-00-1210U
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCW
Product Code Name
Laryngoscope, Rigid
Public Device Record Key
2bc6feed-cbfc-4549-839e-bfe4bc08e907
Public Version Date
March 02, 2020
Public Version Number
1
DI Record Publish Date
February 21, 2020
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 | 715 |
2 | A medical device with a moderate to high risk that requires special controls. | 465 |