| Primary Device ID | 20787551041051 |
| NIH Device Record Key | 06e7aaf9-7345-4f45-81e6-20819e03c678 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPK10812 Surgical BackPack Kit |
| Version Model Number | SPK10812 |
| Catalog Number | SPK10812 |
| Company DUNS | 868042664 |
| Company Name | XODUS MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com | |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com | |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com | |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com | |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com | |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com | |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com | |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com | |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com | |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com | |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com | |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com | |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com | |
| Phone | +1(724)337-5500 |
| plloyd@xodusmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00787551041057 [Primary] |
| GS1 | 20787551041051 [Package] Contains: 00787551041057 Package: CASE [6 Units] In Commercial Distribution |
| CCX | SUPPORT, PATIENT POSITION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-13 |
| Device Publish Date | 2025-02-05 |
| 20787551040108 - 30250 Pink Pad - Loop Strap 29" | 2025-07-24 30250 Pink Pad - Loop Strap 29" |
| 20787551041228 - SPK10488 Jackson Kit | 2025-07-24 SPK10488 Jackson Kit |
| 20787551041235 - PBK10008 Pegboard Kit | 2025-07-24 PBK10008 Pegboard Kit |
| 20787551041242 - SPK11661 Wilson Frame Positioning Kit | 2025-07-24 SPK11661 Wilson Frame Positioning Kit |
| 20787551041259 - SPK11649 Jackson Table Positioning Kit | 2025-07-24 SPK11649 Jackson Table Positioning Kit |
| 20787551041266 - SPK11186 Surgical BackPack Kit | 2025-07-24 SPK11186 Surgical BackPack Kit |
| 20787551041273 - NSCL25306 Custom Med Label Pack | 2025-07-24 NSCL25306 Custom Med Label Pack |
| 20787551041280 - CL25257 Custom Med Label Pack | 2025-07-24 CL25257 Custom Med Label Pack |