Duns Number:012430880
Device Description: Dental syringe Luer Lock 12 cc Non sterile
Catalog Number
5701401
Brand Name
Henry Schein
Version/Model Number
5701401
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
-
Product Code
EIC
Product Code Name
SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
Public Device Record Key
05b1d578-3b50-4d54-8ce0-d361658276ba
Public Version Date
November 05, 2019
Public Version Number
1
DI Record Publish Date
October 28, 2019
Package DI Number
20304040108769
Quantity per Package
12
Contains DI Package
10304040108762
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 |