Primary Device ID | 00810118105623 |
NIH Device Record Key | f8299f29-0f76-499e-b385-7e1aaa093ff3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Avalon Biomed by Zarc BlueShaper PRO sterile File 31mm ZXS-Z5 |
Version Model Number | ZBS31APROS |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810118105623 [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 | 2025-03-18 |
Device Publish Date | 2025-03-10 |
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00810118103711 - NuSmile NuNamel Varnish | 2025-03-26 NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Bubblegum |