Duns Number:012430880
Device Description: OC-Light S Test Strips
Catalog Number
5700610
Brand Name
Henry Schein
Version/Model Number
5700610
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K143325,K143325
Product Code
KHE
Product Code Name
REAGENT, OCCULT BLOOD
Public Device Record Key
54b93c62-0cc5-46a0-afde-39d8d3bf6cce
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
November 14, 2017
Package DI Number
10304040054182
Quantity per Package
50
Contains DI Package
00304040054185
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |