Duns Number:002348191
Device Description: LMA Unique™ (Silicone Cuff) Size 1
Catalog Number
105300-000010
Brand Name
LMA AIRWAY MANAGEMENT
Version/Model Number
IPN041132
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
3beb4f1c-5847-4cc4-8415-1aa00dda87e8
Public Version Date
February 22, 2021
Public Version Number
3
DI Record Publish Date
September 15, 2018
Package DI Number
25060112313459
Quantity per Package
5
Contains DI Package
15060112313452
Package Discontinue Date
February 20, 2021
Package Status
Not in Commercial Distribution
Package Type
Carton
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 |