| Primary Device ID | 00887517943088 |
| NIH Device Record Key | 87989fe0-4b65-4aa8-9e38-492fd8668312 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PGI |
| Version Model Number | 1667597 |
| 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 | |
| Phone | +1(858)909-1800 |
| RA_UDI@nuvasive.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887517943088 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887517943088]
Moist Heat or Steam Sterilization
[00887517943088]
Moist Heat or Steam Sterilization
[00887517943088]
Moist Heat or Steam Sterilization
[00887517943088]
Moist Heat or Steam Sterilization
[00887517943088]
Moist Heat or Steam Sterilization
[00887517943088]
Moist Heat or Steam Sterilization
[00887517943088]
Moist Heat or Steam Sterilization
[00887517943088]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
| 00887517521248 | Posterior Gen Ins Microscope Set |
| 00887517521200 | Posterior General Ins Set |
| 00887517502926 | PGI Distractor, Open Counter Torque |
| 00887517422309 | PGI Disc Cutter, 8mm Micro |
| 00887517419989 | PGI Rongeur, Pituitary Up Biting |
| 00887517419972 | PGI Rongeur, Pituitary Straight |
| 00887517419958 | PGI Rasp, Angled |
| 00887517419941 | PGI Rasp, Straight |
| 00887517419934 | PGI Curette, Up Angled |
| 00887517419927 | PGI Curette, Down Angled |
| 00887517419910 | PGI Curette, Right Angled |
| 00887517419903 | PGI Curette, Left Angled |
| 00887517419590 | PGI Curette, Straight |
| 00887517419071 | PGI Disc Cutter, 12mm |
| 00887517419064 | PGI Disc Cutter, 10mm |
| 00887517419057 | PGI Disc Cutter, 8mm |
| 00887517269591 | PGI Penfield Dissector, 7mm |
| 00887517269584 | PGI Penfield Dissector, 4mm |
| 00887517238467 | PGI T-Handle, Slapping |
| 00887517061249 | PGI Lamina Spreader, TLIF |
| 00887517060334 | PGI Dissector, 7mm TLIF |
| 00887517060327 | PGI Dissector, 4mm TLIF |
| 00887517058072 | PGI Chisel, 7mm Angled |
| 00887517058065 | PGI Chisel, 12mm Straight |
| 00887517058058 | PGI Chisel, 7mm Straight |
| 00887517938183 | PGI II Paddle Shaver, 9mm |
| 00887517938176 | PGI II Paddle Shaver, 8mm |
| 00887517938169 | PGI II Paddle Shaver, 7mm |
| 00887517938152 | PGI II Paddle Shaver, 6mm |
| 00887517054029 | PGI Decorticator, 8mm PLIF |
| 00887517054012 | PGI Decorticator, 14mm PLIF |
| 00887517054005 | PGI Decorticator, 12mm PLIF |
| 00887517053695 | PGI Decorticator, 10mm PLIF |
| 00887517943101 | PGI II Curette, Bayonetted Rt Sharp Lg |
| 00887517943095 | PGI II Curette, Bayonetted Rt Sharp Sm |
| 00887517943088 | PGI II Curette, Bayonetted Left Sharp Lg |
| 00887517943071 | PGI II Curette, Bayonetted Left Sharp Sm |
| 00887517943064 | PGI II Curette, Bayonetted Down Sharp Lg |
| 00887517943057 | PGI II Curette, Bayonetted Down Sharp Sm |
| 00887517943040 | PGI II Curette, Bayonetted Up Sharp Lg |
| 00887517943033 | PGI II Curette, Bayonetted Up Sharp Sm |
| 00887517943026 | PGI II Curette, Bayonetted Str Sharp Lg |
| 00887517943019 | PGI II Curette, Bayonetted Str Sharp Sm |
| 00887517938954 | PGI II Curette, Large Bayoneted Right |
| 00887517938947 | PGI II Curette, Small Bayoneted Right |
| 00887517938930 | PGI II Curette, Large Bayoneted Left |
| 00887517938923 | PGI II Curette, Small Bayoneted Left |
| 00887517938916 | PGI II Curette, Large Bayoneted Down |
| 00887517938909 | PGI II Curette, Small Bayoneted Down |
| 00887517938893 | PGI II Curette, Large Bayoneted Up |