| Primary Device ID | 04546540401724 |
| NIH Device Record Key | d3f881a8-dee1-439a-bb6c-965acfd50897 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TPS |
| Version Model Number | 5100007000 |
| Catalog Number | 5100007000 |
| 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 | true |
| 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 |
| Phone | +1(800)253-3210 |
| Inst.Stryker.cs@Stryker.com |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04546540401724 [Primary] |
| EIA | UNIT, OPERATIVE DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-01-20 |
| Device Publish Date | 2018-09-24 |
| 07613327174892 | Reusable Irrigation Cassette |
| 07613327135619 | Angled Medium "M" Irrigation Clip |
| 07613327116557 | TPS Universal Pla Ster Case Medium |
| 07613327116540 | TPS Universal Pla Ster Case Large |
| 07613327116496 | TPS Ent/Oral Max. Sterilization Case |
| 07613327116489 | System Sterilization Basket |
| 07613327116472 | Handpiece Sterilization Case |
| 07613327116465 | TPS Universal Pla Ster Case Small |
| 07613327116441 | TPS Micro Oscillating Saw Irr. Clip |
| 07613327116434 | TPS Micro Sag Saw Irr. Clip |
| 07613327060607 | Small-Joint Shaver Handpiece |
| 07613327060591 | TPS Footswitch , Two-Pedal |
| 34546540991691 | Connector Cleaner |
| 04546540991676 | Universal Drill Attachment Lubricant |
| 04546540983930 | XL Oscilliating Saw |
| 04546540980816 | Micro Driver |
| 04546540977748 | TPS Micro Oscillating Saw |
| 04546540971272 | Footswitch |
| 04546540970275 | Cord |
| 04546540552747 | Dura Guard Irrigation Tip |
| 04546540401724 | Unidirectional Footswitch |
| 34546540075728 | Disposable Irrigation Cassette, Dual Handpiece |
| 34546540075711 | Disposable Irrigation Cassette |
| 04546540075703 | Micro Reciprocating Saw Irrigation Clip |
| 04546540074768 | Straight Long "AM" Irrigation Clip |
| 04546540074560 | Dura Guard Irrigation Tip |