| Primary Device ID | 00888118099952 |
| NIH Device Record Key | 59219e73-f7c8-4988-a50f-577c2917e667 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IPS |
| Version Model Number | 60-000-11-09 |
| Company DUNS | 826499238 |
| Company Name | KLS-Martin L.P. |
| 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 | 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 | 00888118099952 [Primary] |
| LLZ | System, image processing, radiological |
| PPT | Cranial surgical planning and instrument guides |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
[00888118099952]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2019-12-12 |
| Device Publish Date | 2018-10-24 |
| 10888118117349 | 60-500-03-09 |
| 10888118117332 | 60-500-02-09 |
| 10888118117325 | 60-500-01-09 |
| 10888118097825 | 60-002-10-09 |
| 10888118097818 | 60-002-09-09 |
| 10888118097801 | 60-002-08-09 |
| 10888118097795 | 60-002-07-09 |
| 10888118097788 | 60-002-06-09 |
| 10888118097771 | 60-002-05-09 |
| 00888118117366 | CUTTING GUIDE, RECON, STANDARD, 00162 |
| 00888118117359 | CUTTING GUIDE, RECON, BONE GRAFT, 00161 |
| 00888118115928 | 60-001-52-09 |
| 00888118115904 | 60-001-50-09 |
| 00888118115898 | 60-001-49-09 |
| 00888118115843 | 60-001-44-09 |
| 00888118115836 | 60-001-43-09 |
| 00888118115829 | 60-001-42-09 |
| 00888118115812 | 60-001-41-09 |
| 00888118115799 | 60-001-12-09 |
| 00888118115782 | 60-001-11-09 |
| 00888118115775 | 60-001-10-09 |
| 00888118115768 | 60-001-09-09 |
| 00888118115751 | 60-001-08-09 |
| 00888118115744 | 60-001-07-09 |
| 00888118115737 | 60-001-06-09 |
| 00888118115720 | 60-001-05-09 |
| 00888118115713 | 60-001-04-09 |
| 00888118115706 | 60-001-03-09 |
| 00888118115690 | 60-001-02-09 |
| 00888118115683 | 60-001-01-09 |
| 00888118115676 | 60-001-00-09 |
| 00888118121776 | 60-500-21-09 |
| 00888118120793 | IMPLANT, MIDFACE, 00198, TI-6AL-4V |
| 00888118120786 | IMPLANT, MANDIBLE, CRIB MESH, 00195, 2.0-3.2 MM SCREW, TI-6AL-4V |
| 00888118120595 | IMPLANT, MIDFACE, 00194, PEEK |
| 00888118120090 | CUTTING GUIDE, RECON, CUTTING SLOT |
| 00888118120007 | MARKING GUIDE, RECON/DIST, EXTRA, LARGE |
| 00888118119995 | MARKING GUIDE, RECON/DIST, EXTRA, SMALL |
| 00888118119988 | MARKING GUIDE, W/PLANNING, RECON/DIST |
| 00888118119971 | CUTTING GUIDE, RECON, EXTRA, LARGE |
| 00888118119964 | CUTTING GUIDE, RECON, EXTRA, SMALL |
| 00888118119957 | CUTTING GUIDE, W/PLANNING, RECON |
| 00888118119940 | MARKING GUIDE, ORTHOG/MAND, 00197 |
| 00888118119933 | MARKING GUIDE, ORTHOG/MAX, 00196 |
| 00888118119926 | CUTTING GUIDE, ORTHOG, COMPLEX, 00163 |
| 00888118119919 | CUTTING GUIDE, W/PLANNING, RECON, COMPLEX, 00160 |
| 00888118119902 | MARKING GUIDE, RECON, BONE GRAFT, 00012 |
| 00888118106353 | PEEK, LARGE, PEEK |
| 00888118106018 | IPS, PEEK, PEEK |
| 00888118105653 | PEEK, PEEK |