Primary Device ID | 00348783004892 |
NIH Device Record Key | 915489c9-e2b3-4162-8988-2a160368c034 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sycamore Wood Wedges |
Version Model Number | 9061103 |
Company DUNS | 014789663 |
Company Name | PREMIER DENTAL PRODUCTS COMPANY |
Device Count | 4 |
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 | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00348783004892 [Unit of Use] |
GS1 | 00348783005059 [Primary] |
JEP | Retainer, Matrix |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-08-14 |
Device Publish Date | 2024-08-06 |
00348783005103 | WEDGE BOX OF 400 ASSORTED (13T, 13, 15, UT) |
00348783004922 | WEDGE BOX OF 400 ULTRA THINS |
00348783004939 | WEDGE BOX OF 400 MINI |
00348783004915 | WEDGE BOX OF 400 - 17 |
00348783004908 | WEDGE BOX OF 400 - 16 |
00348783004892 | WEDGE BOX OF 400 - 15 |
00348783004861 | WEDGE BOX OF 400 - 13XT |
00348783004878 | WEDGE BOX OF 400 - 13T |
00348783004885 | WEDGE BOX OF 400 - 13 |