Duns Number:324869601
Device Description: #5 ; suitable for Tracheal Tubes: 8.5 - 11.0 mm I.D. / Laryngeal Tubes: LTS-D #2, #2.5
Catalog Number
-
Brand Name
Biteblock with elastic necktape
Version/Model Number
40-66-050-1
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"
Yes
For Single-Use
Yes
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
CAE
Product Code Name
Airway, Oropharyngeal, Anesthesiology
Public Device Record Key
8ca80007-4ec2-4ef5-aeff-ead04fe1136f
Public Version Date
July 05, 2022
Public Version Number
1
DI Record Publish Date
June 27, 2022
Package DI Number
14250105604952
Quantity per Package
20
Contains DI Package
04250105604955
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 334 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |