Primary Device ID | 10850002615118 |
NIH Device Record Key | 5d77a250-add2-4b69-96d6-aa8c37b9a678 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GammaPod™ Breast Immobilization and Localization S |
Version Model Number | Inner Breast Cup |
Catalog Number | XMSGP030A10.02-001 |
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 |
Total Volume | 580 Milliliter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850002615111 [Unit of Use] |
GS1 | 10850002615118 [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 |