| Primary Device ID | H981SD3884740 |
| NIH Device Record Key | 0eb84ef5-61cb-4345-a341-21bbc7f0d6d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | SD388.474 |
| Catalog Number | SD388474 |
| Company DUNS | 486711679 |
| Company Name | Synthes GmbH |
| 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 | 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)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034706962 [Primary] |
| HIBCC | H981SD3884740 [Secondary] |
| HXQ | CRIMPER, PIN |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H981SD3884740]
Moist Heat or Steam Sterilization
[H981SD3884740]
Moist Heat or Steam Sterilization
[H981SD3884740]
Moist Heat or Steam Sterilization
[H981SD3884740]
Moist Heat or Steam Sterilization
[H981SD3884740]
Moist Heat or Steam Sterilization
[H981SD3884740]
Moist Heat or Steam Sterilization
[H981SD3884740]
Moist Heat or Steam Sterilization
[H981SD3884740]
Moist Heat or Steam Sterilization
[H981SD3884740]
Moist Heat or Steam Sterilization
[H981SD3884740]
Moist Heat or Steam Sterilization
[H981SD3884740]
Moist Heat or Steam Sterilization
[H981SD3884740]
Moist Heat or Steam Sterilization
[H981SD3884740]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-04-26 |
| Device Publish Date | 2016-12-31 |
| 07612334285515 - VOLT | 2024-12-19 VOLT(TM) PROX HUM IMP & INSTR 1 HIGH 3/3 WIDTH ALUM TRAY |
| 10886982346896 - MAXFRAME | 2024-12-17 MAXFRAME AUTOSTRUT (TM) SOFTWARE |
| 10886982347572 - NA | 2024-12-11 RFN-ADVANCED POLYMER INLAY STERILE |
| 10886982330994 - VOLT | 2024-11-22 2.0MM VOLT(TM) ADAPTION PLATE 12H/65MM |
| 07612334260079 - KINCISE | 2024-11-08 KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE |
| 07612334268587 - KINCISE | 2024-11-08 KINCISE(TM) SYSTEM STERILIZATION CASE LID |
| 07612334268679 - KINCISE | 2024-11-08 KINCISE(TM) SYSTEM PRIMARY HIP ADAPTER CASE |
| 07612334268563 - KINCISE | 2024-11-04 KINCISE™ System Automated Surgical Handpiece V2 |