AccessGUDID - DEVICE: Prostate Caddy Rectal Balloon (10860005263117)

GUDID

Device Identifier (DI) Information

Brand Name: Prostate Caddy Rectal Balloon
Version or Model: 3309
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3309
Company Name: Myriad Medical, LLC

Primary DI Number: 10860005263117
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 842448610 *Terms of Use

Device Description: Prostate Immobilization device. Rectal Balloon and inflation syringe, single use, non-sterile. Kit Box of 25.

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":	Yes
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?
31965	Rectal probe	A hand-held manual surgical instrument designed for exploring the tissues and structures of the rectum during a gastroenterological/urological surgical procedure. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PCT	Prostate Immobilizer Rectal Balloon

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: 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: 58e1b90e-4030-493b-b6e6-482140143a75
Public Version Date: October 01, 2020
Public Version Number: 1
DI Record Publish Date: September 23, 2020