AccessGUDID - DEVICE: VISICOIL (B887TLS110720170)

GUDID

Device Identifier (DI) Information

Brand Name: VISICOIL
Version or Model: TLS-110-72017
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TLS-110-72017
Company Name: Izi Medical Products, LLC

Primary DI Number: B887TLS110720170
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 933506164 *Terms of Use

Device Description: Qty2-1.10mmx0.5cm Gold VISICOILS 20mm Spacer 17g x 20cm needle Stranded 2 - 1.10mm x 0.50cm VISICOIL separated by 20mm PGLA spacer (Stranded with PGLA Sleeve) loaded in an 17 gauge pre-waxed brachytherapy needle 20cm in length.

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?
40808	Radiological image marker, implantable	A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KXK	Source, Brachytherapy, Radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120859	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 873e4c89-1e19-43d5-b933-880b9010499b
Public Version Date: September 22, 2023
Public Version Number: 5
DI Record Publish Date: April 30, 2020