Primary Device ID | 88800069209615 |
NIH Device Record Key | f40f1737-7e68-4c21-baeb-a68112b8ab70 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Edge .06 PP |
Version Model Number | SPP3506-1 |
Company DUNS | 688273010 |
Company Name | SURE DENT CORPORATION |
Device Count | 100 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800069209619 [Primary] |
GS1 | 88800069209615 [Unit of Use] |
EKN | Point, Paper, Endodontic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-24 |
Device Publish Date | 2023-08-16 |
88800069209820 | EDGE X7 06 PAPER POINTS ASSORTED - (20,25,30,35,40,45) |
88800069209646 | Edge 06 Paper Points 50.06 |
88800069209639 | Edge 06 Paper Points 45.06 |
88800069209622 | Edge 06 Paper Points 40.06 |
88800069209615 | Edge 06 Paper Points 35.06 |
88800069209608 | Edge 06 Paper Points 30.06 |
88800069209592 | Edge 06 Paper Points 25.06 |
88800069209585 | Edge 06 Paper Points 20.06 |
88800069209578 | Edge 06 Paper Points 15.06 |