AccessGUDID - DEVICE: Advantage-Strand® and Advantage-Load® and Advantage Pd-103® (M936PBKASAL9)

GUDID

Device Identifier (DI) Information

Brand Name: Advantage-Strand® and Advantage-Load® and Advantage Pd-103®
Version or Model: PBKA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ISOAID, L.L.C.

Primary DI Number: M936PBKASAL9
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 9
Labeler D-U-N-S® Number*: 002751241 *Terms of Use

Device Description: Brachytherapy Kit: Advantage-Strand and Advantage-Load with Pd-103 radioactive seeds.

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?
33069	Brachytherapy injection needle	A sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). The device may be pre-sterilized and preloaded, and may have a tip enhanced for ultrasound-guided implantation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXK	Source, Brachytherapy, Radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091117	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: bff65fc2-99dc-40cb-b5c0-6a309a766a9f
Public Version Date: May 03, 2024
Public Version Number: 4
DI Record Publish Date: February 04, 2016