| Primary Device ID | H981608200030 |
| NIH Device Record Key | 97516a97-3209-47aa-9c38-c26a6804c8b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProDisc-C |
| Version Model Number | 60.820.003 |
| Catalog Number | 60820003 |
| 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 | |
| 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 | 10705034797830 [Primary] |
| HIBCC | H981608200030 [Secondary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
Moist Heat or Steam Sterilization
[H981608200030]
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 |
| H98109820077S08 | PRODISC-C IMPLANT EXTRA LARGE DEEP 7MM-STERILE |
| H98109820076S07 | PRODISC-C IMPLANT EXTRA LARGE DEEP 6MM-STERILE |
| H98109820075S06 | PRODISC-C IMPLANT EXTRA LARGE DEEP 5MM-STERILE |
| H98109820067S07 | PRODISC-C IMPLANT EXTRA LARGE 7MM-STERILE |
| H98109820066S06 | PRODISC-C IMPLANT EXTRA LARGE 6MM-STERILE |
| H98109820065S05 | PRODISC-C IMPLANT EXTRA LARGE 5MM-STERILE |
| H98109820057S06 | PRODISC-C IMPLANT LARGE DEEP 7MM-STERILE |
| H98109820056S05 | PRODISC-C IMPLANT LARGE DEEP 6MM-STERILE |
| H98109820055S04 | PRODISC-C IMPLANT LARGE DEEP 5MM-STERILE |
| H98109820047S05 | PRODISC-C IMPLANT LARGE 7MM-STERILE |
| H98109820046S04 | PRODISC-C IMPLANT LARGE 6MM-STERILE |
| H98109820045S03 | PRODISC-C IMPLANT LARGE 5MM-STERILE |
| H98109820037S04 | PRODISC-C IMPLANT MEDIUM DEEP 7MM-STERILE |
| H98109820036S03 | PRODISC-C IMPLANT MEDIUM DEEP 6MM-STERILE |
| H98109820035S02 | PRODISC-C IMPLANT MEDIUM DEEP 5MM-STERILE |
| H98109820027S03 | PRODISC-C IMPLANT MEDIUM 7MM-STERILE |
| H98109820026S02 | PRODISC-C IMPLANT MEDIUM 6MM-STERILE |
| H98109820025S01 | PRODISC-C IMPLANT MEDIUM 5MM-STERILE |
| H981608200040 | SCREW MODULE FOR PRODISC-C |
| H981608200030 | GRAPHIC CASE FOR PRODISC-C REMOVAL SYSTEM |
| 07611819960640 | GRAPHIC CASE FOR PRODISC-C(TM) INSTRUMENTS |