Primary Device ID | 08800037500199 |
NIH Device Record Key | f2bf0c0e-8ae2-44c3-ac50-858759abf371 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Polarfix™ Facet Screw System |
Version Model Number | FSA4550N |
Company DUNS | 688811082 |
Company Name | Innosys Co., Ltd. |
Device Count | 1 |
DM Exempt | true |
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 | true |
Lot Batch | true |
Serial Number | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800037500199 [Primary] |
MRW | SYSTEM, FACET SCREW SPINAL DEVICE |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
[08800037500199]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-06-19 |
Device Publish Date | 2018-08-21 |
08800037500250 | FSA5550N |
08800037500243 | FSA5545N |
08800037500236 | FSA5540N |
08800037500229 | FSA5535N |
08800037500212 | FSA5530N |
08800037500205 | FSA5525N |
08800037500199 | FSA4550N |
08800037500182 | FSA4545N |
08800037500175 | FSA4540N |
08800037500168 | FSA4535N |
08800037500151 | FSA4530N |
08800037500144 | FSA4525N |
08800015994866 | FS0080 |
08800015994859 | FS0070 |
08800015994842 | FS0060 |
08800015994835 | FS0050 |
08800015994828 | FS0040 |
08800015994811 | FS0030 |
08800015994804 | FS0020 |
08800015994798 | FS0010 |
08800015994781 | FSA5550 |
08800015994774 | FSA5545 |
08800015994767 | FSA5540 |
08800015994750 | FSA5535 |
08800015994743 | FSA5530 |
08800015994736 | FSA5525 |
08800015994729 | FSA4550 |
08800015994712 | FSA4545 |
08800015994705 | FSA4540 |
08800015994699 | FSA4535 |
08800015994682 | FSA4530 |
08800015994675 | FSA4525 |
08800037586186 | FS0050 |
08800037586179 | FS0040 |
08800037586162 | FS0010 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() POLARFIX 76520289 not registered Dead/Abandoned |
Polarfix Trading Technologies, Inc 2003-06-06 |