AccessGUDID - DEVICE: GammaTile (00860000064545)

GUDID

Device Identifier (DI) Information

Brand Name: GammaTile
Version or Model: GT-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GT MEDICAL TECHNOLOGIES, INC.

Primary DI Number: 00860000064545
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081299204 *Terms of Use

Device Description: Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
38303	Manual brachytherapy source, permanent implant	A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KXK	Source, Brachytherapy, Radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221539	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
No Device Sizes

Device Record Status

Public Device Record Key: d4fbbf49-c9eb-4f61-9cee-d7288dbf9409
Public Version Date: May 07, 2024
Public Version Number: 1
DI Record Publish Date: April 29, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
20860000064549	2	00860000064545	In Commercial Distribution	Inner Pack
10860000064542	1	00860000064545	In Commercial Distribution	Inner Pack
30860000064546	3	00860000064545	In Commercial Distribution	Inner Pack
40860000064543	4	00860000064545	In Commercial Distribution	Inner Pack
50860000064540	5	00860000064545	In Commercial Distribution	Inner Pack
60860000064547	6	00860000064545	In Commercial Distribution	Inner Pack