| Primary Device ID | B167110040002020 |
| NIH Device Record Key | 795017cd-9fb9-493c-beb7-9c630d8f77f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CURE OPEL-C |
| Version Model Number | 1100-400-02-02 |
| Company DUNS | 182698477 |
| Company Name | MEDITECH SPINE, 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B167110040002020 [Primary] |
| KWQ | Appliance, fixation, spinal intervertebral body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B167110040002020]
Moist Heat or Steam Sterilization
[B167110040002020]
Moist Heat or Steam Sterilization
[B167110040002020]
Moist Heat or Steam Sterilization
[B167110040002020]
Moist Heat or Steam Sterilization
[B167110040002020]
Moist Heat or Steam Sterilization
[B167110040002020]
Moist Heat or Steam Sterilization
[B167110040002020]
Moist Heat or Steam Sterilization
[B167110040002020]
Moist Heat or Steam Sterilization
[B167110040002020]
Moist Heat or Steam Sterilization
[B167110040002020]
Moist Heat or Steam Sterilization
[B167110040002020]
Moist Heat or Steam Sterilization
[B167110040002020]
Moist Heat or Steam Sterilization
[B167110040002020]
Moist Heat or Steam Sterilization
[B167110040002020]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-19 |
| Device Publish Date | 2020-08-11 |