Primary Device ID | 00887517432650 |
NIH Device Record Key | f7ffc071-fe6c-46c2-aed0-aad2cbd68b03 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SpheRx |
Version Model Number | 7216545 |
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 |
Phone | +1(858)909-1800 |
RA_UDI@nuvasive.com | |
Phone | +1(858)909-1800 |
RA_UDI@nuvasive.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00887517432650 [Primary] |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00887517432650]
Moist Heat or Steam Sterilization
[00887517432650]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-10-24 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SPHERX 78405238 3007981 Live/Registered |
NuVasive, Inc. 2004-04-20 |