Duns Number:070556204
Device Description: LMA Supreme Plus Pack, Size 2, incl Syringe and Lubricant, Disposable, 10ea/bx
Catalog Number
-
Brand Name
Curaplex
Version/Model Number
2114-12002
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
FMF
Product Code Name
Syringe, piston
Public Device Record Key
c7887829-288e-4fb1-a72e-bd84fa820946
Public Version Date
September 10, 2019
Public Version Number
4
DI Record Publish Date
December 14, 2016
Package DI Number
00815277020428
Quantity per Package
10
Contains DI Package
00815277020411
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 | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |