Duns Number:002348191
Device Description: Standard/Conventional Laryngoscope Blade Miller Size 0
Catalog Number
008615050
Brand Name
RUSCH
Version/Model Number
IPN040409
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
-
Product Code
CCW
Product Code Name
LARYNGOSCOPE, RIGID
Public Device Record Key
f83a7135-74bc-4cd3-beb9-8ac962189fd1
Public Version Date
January 23, 2020
Public Version Number
2
DI Record Publish Date
September 15, 2018
Package DI Number
24026704540741
Quantity per Package
25
Contains DI Package
04026704540747
Package Discontinue Date
September 30, 2019
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |