Primary Device ID | 88800069209677 |
NIH Device Record Key | 97237e9d-bc0d-4112-9b60-87d6b89249f4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Edge Taper PP |
Version Model Number | ETPPF3-1 |
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 | 08800069209671 [Primary] |
GS1 | 88800069209677 [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 |
88800069209837 | EDGE TAPER PAPER POINTS ASSORTED - (F1-F5) |
88800069209691 | Edge Taper Paper Points F5 |
88800069209684 | Edge Taper Paper Points F4 |
88800069209677 | Edge Taper Paper Points F3 |
88800069209660 | Edge Taper Paper Points F2 |
88800069209653 | Edge Taper Paper Points F1 |