Primary Device ID | 00810118104541 |
NIH Device Record Key | 5e696347-9742-43fb-add3-46b01895fe01 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Avalon Biomed by Zarc Z-Glider EVO File 25mm (015) |
Version Model Number | ZZGE00025 |
Company DUNS | 185497372 |
Company Name | NUSMILE, LTD. |
Device Count | 1 |
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 | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com | |
Phone | 832-540-5964 |
plara@nusmile.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810118104541 [Primary] |
EKS | File, Pulp Canal, Endodontic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-28 |
Device Publish Date | 2024-05-20 |
00810118104565 - NuSmile Signature Anterior Replacement Crown | 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 1 Right - Regular Length / Light Shade |
00810118104572 - NuSmile Signature Anterior Replacement Crown | 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 2 Right - Regular Length / Light Shade |
00810118104589 - NuSmile Signature Anterior Replacement Crown | 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 3 Right - Regular Length / Light Shade |
00810118104596 - NuSmile Signature Anterior Replacement Crown | 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 4 Right - Regular Length / Light Shade |
00810118104602 - NuSmile Signature Anterior Replacement Crown | 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 5 Right - Regular Length / Light Shade |
00810118104619 - NuSmile Signature Anterior Replacement Crown | 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 6 Right - Regular Length / Light Shade |
00810118104626 - NuSmile Signature Anterior Replacement Crown | 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 1 Left - Regular Length / Light Shade |
00810118104633 - NuSmile Signature Anterior Replacement Crown | 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 2 Left - Regular Length / Light Shade |