GammaPod™ Breast Immobilization and Localization S XMSGP030A10.02-017

GUDID 10850002615279

M06

XCISION MEDICAL SYSTEMS, LLC

Stereotactic radiotherapy breast positioning system inner cup
Primary Device ID10850002615279
NIH Device Record Key8c07e4f9-ac71-41c7-8d53-d17a3b2e0ad5
Commercial Distribution StatusIn Commercial Distribution
Brand NameGammaPod™ Breast Immobilization and Localization S
Version Model NumberInner Breast Cup
Catalog NumberXMSGP030A10.02-017
Company DUNS788286941
Company NameXCISION MEDICAL SYSTEMS, LLC
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-924-7466
Emailservice@xcision.com
Phone1-855-924-7466
Emailservice@xcision.com
Phone1-855-924-7466
Emailservice@xcision.com
Phone1-855-924-7466
Emailservice@xcision.com

Device Dimensions

Total Volume670 Milliliter
Total Volume670 Milliliter
Total Volume670 Milliliter
Total Volume670 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850002615272 [Unit of Use]
GS110850002615279 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IWBSystem, Radiation Therapy, Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-29
Device Publish Date2019-03-21

On-Brand Devices [GammaPod™ Breast Immobilization and Localization S]

10850002615354S05
10850002615347S04
10850002615330S03
10850002615323S02
10850002615316S01
10850002615309M09
10850002615293M08
10850002615286M07
10850002615279M06
10850002615262M05
10850002615255M04
10850002615248M03
10850002615231M02
10850002615224M01
10850002615217M00
10850002615200L09
10850002615194L08
10850002615187L07
10850002615170L06
10850002615163L05
10850002615156L04
10850002615149L03
10850002615132L02
10850002615125L01
10850002615118L00
10850002615101Small
10850002615095Medium
10850002615088Large

Trademark Results [GammaPod]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GAMMAPOD
GAMMAPOD
88708772 not registered Live/Pending
Xcision Medical Systems LLC
2019-11-27
GAMMAPOD
GAMMAPOD
77835492 3986402 Dead/Cancelled
Xcision Medical Systems LLC
2009-09-25
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