GammaPod™ XMSGP030A00-0.02

GUDID 00850002615005

Stereotactic Radiotherapy System

XCISION MEDICAL SYSTEMS, LLC

Stereotactic radiosurgical system
Primary Device ID00850002615005
NIH Device Record Keyc49ae7b9-e91e-468c-bf0e-0f91e47a9c5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameGammaPod™
Version Model NumberModel A
Catalog NumberXMSGP030A00-0.02
Company DUNS788286941
Company NameXCISION MEDICAL SYSTEMS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850002615005 [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 Date2019-03-11
Device Publish Date2019-03-01

Devices Manufactured by XCISION MEDICAL SYSTEMS, LLC

00850002615036 - GammaPod™ Imager Loader and Couch2019-04-16 Imager Loader and Couch
10850002615378 - GammaPod™ Breast Immobilization and Localization System 2019-04-03 Elliptical 100-50-16M
10850002615385 - GammaPod™ Breast Immobilization and Localization System 2019-04-03 Elliptical 100-50-23M
10850002615392 - GammaPod™ Breast Immobilization and Localization System 2019-04-03 Elliptical 120-60-20L
10850002615408 - GammaPod™ Breast Immobilization and Localization System 2019-04-03 Elliptical 120-60-30L
10850002615415 - GammaPod™ Breast Immobilization and Localization System 2019-04-03 Skew 80-40-17S
10850002615422 - GammaPod™ Breast Immobilization and Localization System 2019-04-03 Skew 100-50-16M
10850002615439 - GammaPod™ Breast Immobilization and Localization System 2019-04-03 Skew 100-50-23M

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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