SpheRx
GUDID 00887517524041
SpheRx Ins Tray 1
Nuvasive, Inc.
Sterilization/disinfection container| Primary Device ID | 00887517524041 |
| NIH Device Record Key | 5ddcd3f3-e27e-4eeb-ab26-ba4a691a81c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpheRx |
| Version Model Number | SPHER1 |
| Company DUNS | 053950783 |
| Company Name | Nuvasive, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
Customer Support Contacts
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| Phone | +1800-475-9131 |
| nuvainfo@globusmedical.com | |
| Phone | +1800-475-9131 |
| nuvainfo@globusmedical.com | |
| Phone | +1800-475-9131 |
| nuvainfo@globusmedical.com | |
| Phone | +1800-475-9131 |
| nuvainfo@globusmedical.com | |
| Phone | +1800-475-9131 |
| nuvainfo@globusmedical.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887517524041 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143579
FDA Product Code
| KCT | Sterilization wrap containers, trays, cassettes & other accessories |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
[00887517524041]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-09-10 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [SpheRx]
| 00887517524393 | SpheRx PPS Open Ins Tray |
| 00887517524386 | SpheRx PPS Non-Cannulated Screws |
| 00887517524379 | SpheRx PPS Instrument Tray |
| 00887517524362 | SpheRx PPS Implant Tray |
| 00887517524355 | SpheRx PPS Cannulated Screws |
| 00887517524324 | SpheRx PPS 6.25mm Pre-Assm Screwdriver |
| 00887517524317 | SpheRx PPS 6.25mm Imp/Ins Set |
| 00887517524300 | SpheRx PPS 5.5mm Tulip Lock Screws |
| 00887517524270 | SpheRx PPS Reduction, 5.5mm AUS |
| 00887517524263 | SpheRx PPS 5.5mm Imp/Ins Set |
| 00887517524256 | SpheRx 5.5 EXT Ins Set |
| 00887517524249 | SpheRx 5.5 EXT Imp Set |
| 00887517524232 | SpheRx II Sphere Rod/Cross Connect Tray |
| 00887517524225 | SpheRx II Reduction Screw Tray |
| 00887517524188 | SpheRx II Conventional Rod Tray |
| 00887517524171 | SpheRx II Anterior Ins Tray 2 |
| 00887517524164 | SpheRx II Anterior Ins Tray 1 |
| 00887517524157 | SpheRx II Anterior Imp Set |
| 00887517524140 | SpheRx II Hook/Fixed Screw Tray |
| 00887517524133 | SpheRx II Imp Set |
| 00887517524126 | SpheRx II Ins Tray 2 |
| 00887517524102 | SpheRx II Ins Tray 1 |
| 00887517524089 | SpheRx 8.5mm Screw Set |
| 00887517524065 | SpheRx Implant Set |
| 00887517524058 | SpheRx Instrument Tray 2 |
| 00887517524041 | SpheRx Ins Tray 1 |
| 00887517524034 | SpheRx II MAS Ins Tray |
| 00887517524027 | SpheRx II Double Lead Screw Tray |
| 00887517521712 | SpheRx Persuader Set |
| 00887517521385 | PPS Distractor, Open PLIF TLIF |
| 00887517518385 | SpheRx DBR Ins Set |
| 00887517518378 | SpheRx DBR Imp Set |
| 00887517518361 | SpheRx DBR Demo Kit |
| 00887517518354 | SpheRx DBR III Rod Only Tray |
| 00887517518347 | SpheRx DBR III Modular |
| 00887517518330 | SpheRx DBR III MOD Implants/Instruments |
| 00887517518323 | SpheRx DBR III Instrument Tray 2 |
| 00887517518316 | SpheRx DBR III Instrument Tray 1 |
| 00887517518309 | SpheRx DBR III Implant Tray |
| 00887517518286 | SpheRx DBR II Ins Tray 2 |
| 00887517518279 | SpheRx DBR II Ins Tray 1 |
| 00887517518262 | SpheRx DBR II Imp Set |
| 00887517514967 | Alpha Armada Mini Reduction Towers |
| 00887517479419 | SpheRx®II DBR®II Screw, 7.5x60mm Poly |
| 00887517479402 | SpheRx® DBR®II Screw, 7.5x55mm Cann Poly |
| 00887517479297 | SpheRx® DBR®II Screw, 7.5x50mm Cann Poly |
| 00887517479280 | SpheRx® DBR®II Screw, 7.5x45mm Cann Poly |
| 00887517479273 | SpheRx® DBR®II Screw, 7.5x40mm Cann Poly |
| 00887517479266 | SpheRx® DBR®II Screw, 7.5x35mm Cann Poly |
| 00887517479259 | SpheRx® DBR®II Screw, 7.5x30mm Cann Poly |
Trademark Results [SpheRx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPHERX 78405238 3007981 Live/Registered |
NuVasive, Inc. 2004-04-20 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.