| Primary Device ID | 10886982348395 |
| NIH Device Record Key | 47b55b42-70c3-4a09-8df6-24c1c33b8e70 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | SD312.204 |
| Catalog Number | SD312204 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886982348395 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10886982348395]
Moist Heat or Steam Sterilization
[10886982348395]
Moist Heat or Steam Sterilization
[10886982348395]
Moist Heat or Steam Sterilization
[10886982348395]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-26 |
| Device Publish Date | 2025-02-18 |
| 10886982344410 - NA | 2025-02-26 MAXFRAME CONTROL BOX TEMPLATE |
| 10886982348333 - NA | 2025-02-26 1.1MM PARALLEL WIRE GUIDE |
| 10886982348364 - NA | 2025-02-26 1.4MM PARALLEL WIRE GUIDE |
| 10886982348395 - NA | 2025-02-261.6MM PARALLEL WIRE GUIDE |
| 10886982348395 - NA | 2025-02-26 1.6MM PARALLEL WIRE GUIDE |
| 10886982349088 - NA | 2025-02-26 TERMITE REDUCTION FORCEPS SERRATED JAW |
| H6792050550 - NA | 2025-02-20 3.5MM CANNULATED SCREW PARTIALLY THREADED/55MM |
| H6794089050 - NA | 2025-02-20 7.3MM TI CANNULATED SCREW 16MM THREAD/105MM |
| 07612334285515 - VOLT | 2024-12-19 VOLT(TM) PROX HUM IMP & INSTR 1 HIGH 3/3 WIDTH ALUM TRAY |