AccessGUDID - DEVICE: GammaPod™ Breast Immobilization and Localization System (10850002615149)

GUDID

Device Identifier (DI) Information

Brand Name: GammaPod™ Breast Immobilization and Localization System
Version or Model: Inner Breast Cup
Commercial Distribution Status: In Commercial Distribution
Catalog Number: XMSGP030A10.02-004
Company Name: XCISION MEDICAL SYSTEMS, LLC

Primary DI Number: 10850002615149
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 788286941 *Terms of Use

Device Description: L03

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64181	Stereotactic radiotherapy breast positioning system inner cup	A bowl-shaped component of a stereotactic radiotherapy breast positioning system intended to cover/fit onto a female breast, with direct patient contact, to facilitate reproducible positioning/immobilization during stereotactic radiotherapy (SRT) imaging and treatment. It is used in conjunction with an outer cup where a vacuum is formed between the two cups; it is typically made of polymers. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWB	System, Radiation Therapy, Radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180571	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1020 Milliliter

Device Record Status

Public Device Record Key: 454dff1f-02f0-45ba-989e-746bc959f5b2
Public Version Date: March 29, 2019
Public Version Number: 1
DI Record Publish Date: March 21, 2019