Duns Number:012430880
Device Description: SYRINGE W/O NEEDLE LUERLO 30cc
Catalog Number
5702623
Brand Name
Henry Schein
Version/Model Number
5702623
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K113091,K113091,K113091
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
94eca04b-797d-4149-acad-ecee16bc6a2a
Public Version Date
May 07, 2021
Public Version Number
1
DI Record Publish Date
April 29, 2021
Package DI Number
20304040055797
Quantity per Package
8
Contains DI Package
10304040055790
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 |