Duns Number:007941230
Device Description: Cover Light Handle Flexible 3 Per Pack Sterile Not Made With Natural Rubber Latex MediChoi Cover Light Handle Flexible 3 Per Pack Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
LHC1003
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053321,K053321,K053321
Product Code
FTA
Product Code Name
Light, surgical, accessories
Public Device Record Key
9bc215c1-b707-4542-98c2-8c95406a1349
Public Version Date
November 22, 2018
Public Version Number
4
DI Record Publish Date
August 20, 2016
Package DI Number
50885632114654
Quantity per Package
64
Contains DI Package
10885632114656
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |