| Primary Device ID | 07611819109216 |
| NIH Device Record Key | bddc35fe-f8b1-4920-9970-ecad7821860d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SynFrame |
| Version Model Number | 387.337 |
| Catalog Number | 387337 |
| 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 | |
| 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 | 07611819109216 [Direct Marking] |
| GS1 | 10705034771069 [Primary] |
| HIBCC | H9813873370 [Secondary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
[07611819109216]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-04-27 |
| Device Publish Date | 2016-12-31 |
| 07611819813731 | SYNFRAME FLEX ARM BRIDGE |
| H981SD3873600 | SYNFRAME GUIDE ROD WITH CLAMP |
| H981SD3873590 | SYNFRAME GUIDE ROD-SHORT |
| H981SD3873580 | SYNFRAME GUIDE ROD-RIGID |
| H981SD3873570 | SYNFRAME GUIDE ROD- 50 DEG ANGLE |
| H981SD3873560 | HOLDER FOR SYNFRAME BONE LEVERS-SHORT |
| H981SD3873470 | SYNFRAME RING CLAMP-REVERSED |
| H981SD3873460 | ADAPTER FOR SYNFRAME |
| H981SD3873610 | SYNFRAME GUIDE ROD LONG |
| 07611819110144 | SYNFRAME BONE LEVER- 18MM WIDTH/150MM |
| 07611819110137 | SYNFRAME BONE LEVER- 18MM WIDTH/130MM |
| 07611819110120 | SYNFRAME BONE LEVER- 8MM WIDTH/160MM |
| 07611819110113 | SYNFRAME BONE LEVER- 8MM WIDTH/130MM |
| 07611819110106 | SYNFRAME BONE LEVER- 8MM WIDTH/100MM |
| 07611819113169 | SYNFRAME RIB RETRACTOR- 40MM WIDTH/50MM |
| 07611819113152 | SYNFRAME RIB RETRACTOR- 30MM WIDTH/40MM |
| H9813874370 | SYNFRAME RETRACTOR- 50MM WIDTH/180MM |
| 07611819759381 | SYNFRAME RETRACTOR- 50MM WIDTH/160MM |
| 07611819759374 | SYNFRAME RETRACTOR- 50MM WIDTH/140MM |
| H9813874340 | SYNFRAME RETRACTOR- 50MM WIDTH/120MM |
| H9813874330 | SYNFRAME RETRACTOR- 50MM WIDTH/100MM |
| H9813874320 | SYNFRAME RETRACTOR- 23MM WIDTH/220MM |
| H9813874310 | SYNFRAME RETRACTOR- 23MM WIDTH/200MM |
| 07611819099524 | SYNFRAME RETRACTOR 140MM |
| 07611819238992 | SYNFRAME RETRACTOR HOLDER- ADJUSTABLE |
| 07611819099005 | SYNFRAME GUIDE ROD |
| 07611819110175 | HOLDER FOR SYNFRAME BONE LEVERS |
| 07611819098985 | SYNFRAME TUBE-TO-TUBE CLAMP |
| 07611819141278 | SYNFRAME RING CLAMP |
| 07611819141261 | SYNFRAME INSULATED TABLE CLAMP |
| 07611819098954 | SYNFRAME CONNECTING ROD |
| 07611819098947 | SYNFRAME ANGLED ROD |
| 07611819098930 | SYNFRAME ANGLED ROD HOLDER |
| 07611819109230 | SYNFRAME LENGTHENER |
| 07611819109216 | SYNFRAME HALF RING |
| 07611819109223 | SYNFRAME HOLDING RING TWO-PIECE |
| 07611819255913 | SYNFRAME HOLDING RING-SMALL 2 PIECE-240MM DIAMETER |
| 07611819255906 | SYNFRAME EXTENSION-ADJUSTABLE |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SYNFRAME 78943760 3268141 Live/Registered |
DEPUY SYNTHES, INC. 2006-08-03 |