| Primary Device ID | 10850002615262 |
| NIH Device Record Key | 3e919d86-6647-4d3f-a6dc-24482271c46e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GammaPod™ Breast Immobilization and Localization S |
| Version Model Number | Inner Breast Cup |
| Catalog Number | XMSGP030A10.02-016 |
| Company DUNS | 788286941 |
| Company Name | XCISION MEDICAL SYSTEMS, LLC |
| Device Count | 20 |
| 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 | 1-855-924-7466 |
| service@xcision.com | |
| Phone | 1-855-924-7466 |
| service@xcision.com | |
| Phone | 1-855-924-7466 |
| service@xcision.com | |
| Phone | 1-855-924-7466 |
| service@xcision.com |
| Total Volume | 610 Milliliter |
| Total Volume | 610 Milliliter |
| Total Volume | 610 Milliliter |
| Total Volume | 610 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850002615265 [Unit of Use] |
| GS1 | 10850002615262 [Primary] |
| IWB | System, Radiation Therapy, Radionuclide |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-29 |
| Device Publish Date | 2019-03-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GAMMAPOD 88708772 not registered Live/Pending |
Xcision Medical Systems LLC 2019-11-27 |
![]() GAMMAPOD 77835492 3986402 Dead/Cancelled |
Xcision Medical Systems LLC 2009-09-25 |