| Primary Device ID | 00868623000353 |
| NIH Device Record Key | d5b8b3cd-ad2c-4947-bf53-6b031e8919ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Colorado Therapeutics Xenograft Implant |
| Version Model Number | XI-S+ |
| Catalog Number | XI0203-S+ |
| Company DUNS | 080356428 |
| Company Name | COLORADO THERAPEUTICS 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 3034699459 |
| info@co-therapeutics.com |
| Length | 3 Centimeter |
| Length | 3 Centimeter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868623000353 [Primary] |
| FTM | Mesh, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00868623000353]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-13 |
| Device Publish Date | 2019-03-05 |
| 00868623000360 | XI-S+ |
| 00868623000353 | XI-S+ |
| 00868623000346 | XI-S+ |
| 00868623000339 | XI-S+ |
| 00868623000322 | XI-S+ |
| 00868623000315 | XI-S+ |
| 00868623000308 | XI-S+ |
| 00860002305141 | XI-S+ |
| 00860002305134 | XI-S+ |
| 00860002305127 | XI-S+ |
| 00860002305110 | XI-S+ |
| 00860002305103 | XI-S+ |