| Primary Device ID | 07611819738577 |
| NIH Device Record Key | 2aecb93f-6c22-4e3c-8ccf-0097791ff779 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACF |
| Version Model Number | 396.921 |
| Catalog Number | 396921 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| 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 | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07611819738577 [Direct Marking] |
| GS1 | 10705034777917 [Primary] |
| HIBCC | H9813969210 [Secondary] |
| HWT | TEMPLATE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
[07611819738577]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-05 |
| Device Publish Date | 2019-06-27 |
| 07611819738607 | ACF DETACHABLE TRIAL SPACER LORDOTIC 8MM |
| 07611819738584 | ACF DETACHABLE TRIAL SPACER LORDOTIC 6MM |
| 07611819738577 | ACF DETACHABLE TRIAL SPACER LORDOTIC 5MM |
| 07611819233911 | ACF TRIAL SPACER HANDLE |
| 07611819738744 | ACF DETACHABLE TRIAL SPACER CONVEX 10MM |
| 07611819738720 | ACF DETACHABLE TRIAL SPACER CONVEX 9MM |
| 07611819738706 | ACF DETACHABLE TRIAL SPACER CONVEX 8MM |
| 07611819738683 | ACF DETACHABLE TRIAL SPACER CONVEX 7MM |
| 07611819738652 | ACF DETACHABLE TRIAL SPACER CONVEX 6MM |
| 07611819738645 | ACF DETACHABLE TRIAL SPACER CONVEX 5MM |
| 07611819738638 | ACF DETACHABLE TRIAL SPACER LORDOTIC 10MM |
| 07611819738621 | ACF DETACHABLE TRIAL SPACER LORDOTIC 9MM |
| 07611819978157 | IMPLANT HOLDER FOR ACF ALLOGRAFT SPACERS |
| H9813963840 | ACF SPACER IMPLANT HOLDER |
| H9813890780 | SPN CORRECTION ACF EXTENDED IMPLANT HOLDER |
| H9813890770 | SPN CORRECTION ACF TRIAL SPACER HANDLE |
| 07611819473119 | ACF HOLDER |
| H9816900300 | ANTERIOR CERVICAL FUSION INSTRUMENT SET GRAPHIC CASE |
| H9813048240 | ACF GRAPHIC CASE |