| Primary Device ID | 00887517078568 |
| NIH Device Record Key | 8284c644-9935-48a4-b2fb-1835184ad9db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PCM |
| Version Model Number | 7674101 |
| Company DUNS | 053950783 |
| Company Name | Nuvasive, Inc. |
| 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(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887517078568 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887517078568]
Moist Heat or Steam Sterilization
[00887517078568]
Moist Heat or Steam Sterilization
[00887517078568]
Moist Heat or Steam Sterilization
[00887517078568]
Moist Heat or Steam Sterilization
[00887517078568]
Moist Heat or Steam Sterilization
[00887517078568]
Moist Heat or Steam Sterilization
[00887517078568]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-15 |
| Device Publish Date | 2024-04-05 |
| 00887517525178 | Terraced Reamer General Instrument Set |
| 00887517521118 | PCM Instrument Set |
| 00887517521095 | PCM Implant Set |
| 00887517084071 | PCM Trial, 8.0 mm Cervical Disc, Large |
| 00887517084064 | PCM Trial, 7.2 mm Cervical Disc, Large |
| 00887517084057 | PCM Trial, 6.5mm Cervical Disc, Large |
| 00887517084040 | PCM Trial, 8.0 mm Cervical Disc, Medium |
| 00887517084033 | PCM Trial, 7.2 mm Cervical Disc, Medium |
| 00887517084026 | PCM Trial, 6.5mm Cervical Disc, Medium |
| 00887517084019 | PCM Trial, 8.0 mm Cervical Disc, Small |
| 00887517084002 | PCM Trial, 7.2 mm Cervical Disc, Small |
| 00887517083593 | PCM Trial, 6.5mm Cervical Disc, Small |
| 00887517083579 | PCM Driver, Final (US) |
| 00887517083562 | PCM Inserter |
| 00887517083555 | PCM Loading Block |
| 00887517083166 | PCM Driver, Caspar Pin (US) |
| 00887517083159 | PCM Guide, 12mm Distraction Screw (US) |
| 00887517083142 | PCM Guide, 10mm Distraction Screw (US) |
| 00887517083135 | PCM Spacer Wedge, 8.0mm (US) |
| 00887517083128 | PCM Spacer Wedge, 6.5mm (US) |
| 00887517083111 | PCM Cervical Disc Sterilization Tray Nipple Mat |
| 00887517083104 | PCM Cervical Disc Instrument Tray, Bottom |
| 00887517082596 | PCM Cervical Disc Instrument Tray, Middle |
| 00887517082589 | PCM Cervical Disc Instrument Tray, Top |
| 00887517082572 | PCM Cervical Disc Instrument Case Lid |
| 00887517082565 | PCM Cervical Disc Instrument Case Base |
| 00887517081605 | Artificial Vertebral Disc, 8.0 mm Large |
| 00887517081193 | Artificial Vertebral Disc, 7.2 mm Large |
| 00887517081186 | Artificial Vertebral Disc, 6.5 mm Large |
| 00887517081179 | Artificial Vertebral Disc, 8.0 mm Medium |
| 00887517081162 | Artificial Vertebral Disc, 7.2 mm Medium |
| 00887517081155 | Artificial Vertebral Disc, 6.5 mm Medium |
| 00887517081148 | Artificial Vertebral Disc, 8.0 mm Small |
| 00887517081131 | Artificial Vertebral Disc, 7.2 mm Small |
| 00887517081124 | Artificial Vertebral Disc, 6.5mm Small |
| 00887517080752 | PCM Kerrison, 8.0mm Rim Wedge |
| 00887517080745 | PCM Kerrison, 7.2mm Rim Wedge |
| 00887517080738 | PCM Kerrison, 6.5mm Rim Wedge |
| 00887517080721 | PCM Kerrison, 5.7mm Rim Wedge |
| 00887517079046 | PCM Guide, Burr Sterile Rim |
| 00887517079039 | PCM Kerrison, Rim |
| 00887517079008 | PCM Broach, 5.7/6.5 Medium Modular |
| 00887517078599 | PCM Broach, 5.7/6.5 Small Modular |
| 00887517078551 | PCM Handle, Modular |
| 00887517078544 | PCM Drill, Modular Flange |
| 00887517078537 | PCM Screwdriver, Fixation |
| 00887517077349 | PCM Driver, Final |
| 00887517076502 | PCM Guide, Spacer Wedge |
| 00887517075994 | PCM Guide, Spacer Wedge |
| 00887517075987 | PCM Guide, Distraction Screw |