Duns Number:012430880
Device Description: Sharps Container 5.4 Quart
Catalog Number
1127151
Brand Name
Henry Schein
Version/Model Number
1127151
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130281,K130281
Product Code
MMK
Product Code Name
Container, sharps
Public Device Record Key
51343e5e-b908-44f8-8318-57b4f222a316
Public Version Date
March 08, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10304040007409
Quantity per Package
20
Contains DI Package
00304040007402
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 |