Duns Number:012430880
Device Description: ASPIRATING SYRINGE PETITE
Catalog Number
5700410
Brand Name
Henry Schein
Version/Model Number
5700410
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
-
Product Code
EJI
Product Code Name
Syringe, cartridge
Public Device Record Key
63d1f927-e43b-4a33-a327-1e9b35869282
Public Version Date
November 22, 2018
Public Version Number
2
DI Record Publish Date
May 21, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |