| Primary Device ID | 37613327117036 |
| NIH Device Record Key | 3795e49e-5854-4a57-a7eb-148df7fc9e7f |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 5100901906 |
| Catalog Number | 5100-901-906 |
| Company DUNS | 196548481 |
| Company Name | STRYKER CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| 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 | 07613327117035 [Primary] |
| GS1 | 37613327117036 [Package] Contains: 07613327117035 Package: pack [2 Units] In Commercial Distribution |
| EIA | UNIT, OPERATIVE DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 8 |
| Public Version Date | 2020-01-20 |
| Device Publish Date | 2016-09-23 |
| 07613327601695 - Connected OR Hub | 2025-06-12 |
| 07613327601701 - SDC4K Information Management System | 2025-06-12 |
| 07613327482706 - N/A | 2025-05-08 System 9 Transfer Shield, Small |
| 07613327163278 - NA | 2025-04-28 |
| 07613327601138 - OptaBlate | 2025-04-25 Curve 10mm Probe Single Kit |
| 07613327601145 - OptaBlate | 2025-04-25 Curve 20mm Probe Single Kit |
| 07613327601152 - OptaBlate | 2025-04-25 Curve 15mm Probe Single Kit |
| 07613327631883 - OptaBlate | 2025-04-25 Straight 10MM Probe Dual Kit |