Duns Number:041674552
Device Description: Disposable Pen Light w/Pupil Gauge
Catalog Number
Not Applicable
Brand Name
MedSource Disposable Pen Light
Version/Model Number
MS-PEL100-RCS
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KYT
Product Code Name
Light, Examination, Medical, Battery Powered
Public Device Record Key
6c78bb64-6969-4bbf-a16c-188c849a826d
Public Version Date
August 13, 2021
Public Version Number
1
DI Record Publish Date
August 05, 2021
Package DI Number
00816703028940
Quantity per Package
50
Contains DI Package
00816703028926
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 | 498 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |