Duns Number:825673239
Device Description: AMSure®LIGHT HANDLE COVERCAUTION: Avoid freezing and excessive heat.
Catalog Number
LHC002
Brand Name
AMSure® LIGHT HANDLE COVER
Version/Model Number
1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MDM
Product Code Name
Instrument, Manual, Surgical, General Use
Public Device Record Key
3ffb2dcf-9de4-4f01-bd60-7999ab7c4a9f
Public Version Date
September 06, 2019
Public Version Number
1
DI Record Publish Date
August 29, 2019
Package DI Number
40704411011126
Quantity per Package
100
Contains DI Package
10704411011125
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |