Duns Number:012430880
Device Description: Stainless Steel Introductory Kit. 4 x yellow size 0 stainless steel posts, 4 x red size 1 Stainless Steel Introductory Kit. 4 x yellow size 0 stainless steel posts, 4 x red size 1 stainless steel posts, 4 x blue size 2 stainless steel posts; 1 x yellow size 0 primary reamer, 1 x red size 1 primary reamer, 1 x blue size 2 primary reamer; 1 x yellow size 0 secondary drill, 1 x red size 1 secondary drill, 1 x blue size 2 secondary drill; 1 x extender; 1 x internal wrench, 1 x external wrench; 1 x gauge card.
Catalog Number
5701371
Brand Name
Henry Schein
Version/Model Number
5701371
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ELR
Product Code Name
POST, ROOT CANAL
Public Device Record Key
341a32a1-4ebc-4613-9584-c77604f85812
Public Version Date
May 06, 2019
Public Version Number
1
DI Record Publish Date
April 26, 2019
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 |