Duns Number:108999095
Device Description: Disposable Penlight, 6/pkg,White w/Pupil Gauge, LA PL
Catalog Number
351PLA
Brand Name
Life-Assist®
Version/Model Number
351PLA
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)
Yes
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
73b85e48-aedb-4bdc-b6c3-bca546679b19
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
00634782862749
Quantity per Package
6
Contains DI Package
00634782062934
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2395 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1769 |