Duns Number:080361159
Device Description: LARYNGEAL AIRWAY MASK, SZ4, STERILE W/O SYR LUBRICANT, 1/EA
Catalog Number
-
Brand Name
TIGER MEDICAL LARYNGEAL MASKS
Version/Model Number
MLT402
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)
Yes
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
CAE
Product Code Name
Airway, Oropharyngeal, Anesthesiology
Public Device Record Key
e1b4822d-faf6-4d5a-b85a-1ade0bdb779a
Public Version Date
August 01, 2022
Public Version Number
1
DI Record Publish Date
July 22, 2022
Package DI Number
10840216101552
Quantity per Package
5
Contains DI Package
00840216101555
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |