| Primary Device ID | 00819824021654 |
| NIH Device Record Key | 96fe6da1-cfbd-4811-aa83-8337aa3524de |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XULTAN 5.5 PEDICLE SCREW 7.5 X 60 MM NON-CANN |
| Version Model Number | 50756001 |
| Catalog Number | 50756001 |
| Company DUNS | 080474650 |
| Company Name | MET 1 TECHNOLOGIES, LLC |
| 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 | 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 | 9154726762 |
| yone@met1tech.com | |
| Phone | 9154726762 |
| yone@met1tech.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819824021654 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00819824021654]
Moist Heat or Steam Sterilization
[00819824021654]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-28 |
| 00819824021654 | THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE |
| 00819824021524 | THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE |