Primary Device ID | 00860002099378 |
NIH Device Record Key | b965b77f-6ada-40af-83fa-4dca3fda60a5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Premium Teeth Resin - HT A2 |
Version Model Number | FLPTA201 |
Company DUNS | 106744280 |
Company Name | FORMLABS OHIO INC. |
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 | false |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860002099378 [Primary] |
PZY | Additively Manufactured, Preformed, Resin Denture Tooth |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-02-09 |
Device Publish Date | 2024-02-01 |
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