Duns Number:135942121
Device Description: 10.47 liters sharps container pre-filled with a liquid monomer. Simply fill with sharps (n 10.47 liters sharps container pre-filled with a liquid monomer. Simply fill with sharps (needles, blades, endo files, empty carpules and any other potential sharps), when full, the ‘catalyst’ packs are added causing the liquid to heat and convert into solid plastic polymer, safely encapsulating and rendering the sharps unusable and non-recognizable; making them safe for the regular trash, if acceptable under state and local regulations.
Catalog Number
SMS10000
Brand Name
Isolyser/SMS
Version/Model Number
SMS10000
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090156,K090156
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
cd12c769-8447-42a0-bf8a-e3a8f203d72f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 12, 2016
Package DI Number
10858629005039
Quantity per Package
2
Contains DI Package
00858629005032
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |