| Primary Device ID | 00810038095196 |
| NIH Device Record Key | 09471dc0-5807-4744-b99d-6cc2505ea327 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rally™ |
| Version Model Number | FPCK02-X |
| Catalog Number | FPCK02-X |
| Company DUNS | 057647005 |
| Company Name | GARRISON DENTAL SOLUTIONS, L.L.C. |
| 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 | 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 |
| Phone | 888-437-0032 |
| gds@garrisondental.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810038095196 [Primary] |
| EHJ | Disk, Abrasive |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810038095196]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-04 |
| Device Publish Date | 2020-04-24 |
| 00810038095226 | Composite Polisher Trial Pack: 6 Polishers (1 of Each) |
| 00810038095219 | Composite Polisher Trial Pack: 18 Polishers (3 of Each) |
| 00810038095202 | Composite Polisher Point Assortment Pack: 24 Polishers (10) Coarse Points, (10) Medium Points, ( |
| 00810038095196 | Composite Polisher Cup Assortment Pack: 24 Polishers (10) Coarse Cups, (10) Medium Cups, (4) Fin |
| 00810038095189 | Composite Polisher Assortment Pack: 24 Polishers (5) Coarse Points, (5) Coarse Cups, (5) Medium |
| 00810038095172 | Composite Polisher Assortment Pack: 60 Polishers (10 of Each) |
| 00810038093895 | Composite Polisher, Medium Grit Cup, Red |
| 00810038093888 | Composite Polisher, Medium Grit Cup, Red |
| 00810038093871 | Composite Polisher, Medium Grit Point, Red |
| 00810038093864 | Composite Polisher, Medium Grit Point, Red |
| 00810038093857 | Composite Polisher, Fine Grit Cup, Gray |
| 00810038093840 | Composite Polisher, Fine Grit Point, Gray |
| 00810038093833 | Composite Polisher, Coarse Grit Cup, Blue |
| 00810038093826 | Composite Polisher, Coarse Grit Point, Blue |
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