Duns Number:315304071
Device Description: INSUFFLATION / SUCTION TUBE TL 102MM internal, for use with OP laryngoscopes 824201000, r INSUFFLATION / SUCTION TUBE TL 102MM internal, for use with OP laryngoscopes 824201000, reusable
Catalog Number
824201012
Brand Name
NA
Version/Model Number
824201012
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
CCW
Product Code Name
LARYNGOSCOPE, RIGID
Public Device Record Key
7d193243-83cb-4bbb-9891-52bff3c9c7ba
Public Version Date
February 21, 2022
Public Version Number
1
DI Record Publish Date
February 11, 2022
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 |