Duns Number:012430880
Device Description: Maxicide OPA 28
Catalog Number
1126976
Brand Name
Henry Schein
Version/Model Number
1126976
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
K120306,K120306
Product Code
MED
Product Code Name
Sterilant, medical devices
Public Device Record Key
205135a8-da20-4119-af33-df017b053efb
Public Version Date
March 19, 2021
Public Version Number
6
DI Record Publish Date
September 09, 2016
Package DI Number
10304040005368
Quantity per Package
4
Contains DI Package
00304040005361
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 | 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 |