Duns Number:002348191
Device Description: MADgic Atomizer with 3 mL Syringe
Catalog Number
AMG600SU
Brand Name
LMA ATOMIZATION
Version/Model Number
IPN056585
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
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
K153470,K153470,K153470
Product Code
CCT
Product Code Name
APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA
Public Device Record Key
aec1e56d-cf73-46f1-9c8b-0b0aaa155509
Public Version Date
August 07, 2020
Public Version Number
1
DI Record Publish Date
July 30, 2020
Package DI Number
24026704717532
Quantity per Package
25
Contains DI Package
14026704717535
Package Discontinue Date
-
Package Status
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 |