Duns Number:081277700
Device Description: Endo Stop Dispenser - Green, 250/PK
Catalog Number
700510-4000-001
Brand Name
Integra® Miltex®
Version/Model Number
700510-4000-001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 01, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EKS
Product Code Name
FILE, PULP CANAL, ENDODONTIC
Public Device Record Key
bfbeba6f-c932-452f-bec5-f0b822d4c383
Public Version Date
July 19, 2022
Public Version Number
2
DI Record Publish Date
October 07, 2020
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 | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |