AccessGUDID - DEVICE: AOS Implant Needle, Series-17, 15 cm, 30° (00850645007069)

GUDID

Device Identifier (DI) Information

Brand Name: AOS Implant Needle, Series-17, 15 cm, 30°
Version or Model: NID0001-008
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALPHA-OMEGA SERVICES, INC.

Primary DI Number: 00850645007069
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 060398989 *Terms of Use

Device Description: Needle, Implant, Series-17, 15 cm, 30°, 10 ea

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):	No
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?
38436	General-purpose brachytherapy system applicator, remote-afterloading	A general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area. This device includes a variety of applicators (e.g., hollow needle, tube, catheter), and their associated components [e.g., introducer sheath, guidewire].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAQ	System, Applicator, Radionuclide, Remote-Controlled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization
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: 2720b278-1e98-49af-ab59-c9c3cf190146
Public Version Date: February 07, 2019
Public Version Number: 4
DI Record Publish Date: October 05, 2016