| Primary Device ID | B806RO0830I4040 |
| NIH Device Record Key | 27275e03-59c0-4d5a-b10b-d72667bff155 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Implant Holder with Drill Guides W20 x H04 mm |
| Version Model Number | RO0830I404 |
| Catalog Number | RO0830I404 |
| Company DUNS | 116999578 |
| Company Name | Spineup, Inc. |
| 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 |
| Phone | 786-910-0234 |
| contact@upgroup.tech | |
| Phone | 786-910-0234 |
| contact@upgroup.tech | |
| Phone | 786-910-0234 |
| contact@upgroup.tech | |
| Phone | 786-910-0234 |
| contact@upgroup.tech | |
| Phone | 786-910-0234 |
| contact@upgroup.tech | |
| Phone | 786-910-0234 |
| contact@upgroup.tech | |
| Phone | 786-910-0234 |
| contact@upgroup.tech | |
| Phone | 786-910-0234 |
| contact@upgroup.tech | |
| Phone | 786-910-0234 |
| contact@upgroup.tech | |
| Phone | 786-910-0234 |
| contact@upgroup.tech | |
| Phone | 786-910-0234 |
| contact@upgroup.tech | |
| Phone | 786-910-0234 |
| contact@upgroup.tech | |
| Phone | 786-910-0234 |
| contact@upgroup.tech | |
| Phone | 786-910-0234 |
| contact@upgroup.tech |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B806RO0830I4040 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B806RO0830I4040]
Moist Heat or Steam Sterilization
[B806RO0830I4040]
Moist Heat or Steam Sterilization
[B806RO0830I4040]
Moist Heat or Steam Sterilization
[B806RO0830I4040]
Moist Heat or Steam Sterilization
[B806RO0830I4040]
Moist Heat or Steam Sterilization
[B806RO0830I4040]
Moist Heat or Steam Sterilization
[B806RO0830I4040]
Moist Heat or Steam Sterilization
[B806RO0830I4040]
Moist Heat or Steam Sterilization
[B806RO0830I4040]
Moist Heat or Steam Sterilization
[B806RO0830I4040]
Moist Heat or Steam Sterilization
[B806RO0830I4040]
Moist Heat or Steam Sterilization
[B806RO0830I4040]
Moist Heat or Steam Sterilization
[B806RO0830I4040]
Moist Heat or Steam Sterilization
[B806RO0830I4040]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-09 |
| Device Publish Date | 2024-10-01 |
| B806RO0830I4040 | Implant Holder with Drill Guides W20 x H04 mm |
| B806RO0829I3130 | Implant Holder with Drill Guides W20 x H04 mm |