| Primary Device ID | 00190730009807 |
| NIH Device Record Key | 0e7ff57d-e77e-4d11-a6d8-74f097687b33 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Galaxy |
| Version Model Number | 88603 |
| Company DUNS | 781772017 |
| Company Name | ORTHO TECHNOLOGY, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | 00190730009807 [Primary] |
| EHM | STRIP, POLISHING AGENT |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-23 |
| Device Publish Date | 2018-02-20 |
| 00190730009807 | Perforated Strip Narrow ExFine 10/pk 2.5mm wide 15 micron |
| 00190730009791 | Perforated Strips Narrow Fine 10/pk 2.5mm wide 30 micron |
| 00190730009784 | Perforated Strips Narrow Med 10/pk 2.5mm wide 45 micron |
| 00190730009777 | Perforated Strips Narrow Kit 9/pk 3 each type 2.5mm wide |
| 00190730009760 | Perforated Strips Wide Ex.Fine 10/pk 3.75mm wide 15 micron |
| 00190730009753 | Perforated Strips Wide Fine 10/pk 3.75mm wide 30 micron |
| 00190730009746 | Perforated Strips Wide Med 10/pk 3.75mm wide 45 micron |
| 00190730009739 | Perforated Strips Wide Kit 9/pk 3 each type 3.75mm wide |
| 00190730009722 | Galaxy 7901 Debonding Bur-Short Flame 12 Fluted High Speed 5/PK |
| 00190730030702 | Galaxy Interproximal Reduction 6pc Gauge Set |
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