AccessGUDID - DEVICE: Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E) (00815568020977)

GUDID

Device Identifier (DI) Information

Brand Name: Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E)
Version or Model: 708-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KOBOLD, LLC

Primary DI Number: 00815568020977
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 014292258 *Terms of Use

Device Description: Labelled with CE mark

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
38409	Cervical/intrauterine brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in cervical or intrauterine radiation therapy treatments. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the cervical or intrauterine anatomy. This GMDN code includes a wide variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components.	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: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Barrel-shaped ovoids

Device Record Status

Public Device Record Key: 50656a18-749a-4ba2-87af-882e87f15a5b
Public Version Date: December 16, 2019
Public Version Number: 2
DI Record Publish Date: March 25, 2019