| Primary Device ID | H9813048240 |
| NIH Device Record Key | 5c8081b4-713f-4eff-91d9-523b7a3b0c6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACF |
| Version Model Number | 304.824 |
| Catalog Number | 304824 |
| 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 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| 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 |
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| 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 | |
| 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 | 10705034767796 [Primary] |
| HIBCC | H9813048240 [Secondary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
[H9813048240]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-10-21 |
| Device Publish Date | 2016-12-31 |
| 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 |