AccessGUDID - DEVICE: Sitzmarks Radiopaque Markers (00610858081016)

GUDID

Device Identifier (DI) Information

Brand Name: Sitzmarks Radiopaque Markers
Version or Model: Double D
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KONSYL PHARMACEUTICALS, INC.

Primary DI Number: 00610858081016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 102463866 *Terms of Use

Device Description: No description.

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?
58359	Gastrointestinal telemetric monitoring system capsule, non-sterile	A non-sterile, battery-powered (conventional or physiologic), electronic component of a gastrointestinal telemetric monitoring system designed to be swallowed by a patient for the wireless transmission of one or more gastrointestinal parameter signals (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding). The capsule contains a sensor(s) and the telemetric signals it produces are detected by an extracorporeal (e.g., patient-worn) receiver or transceiver; information is displayed by the receiver, or transmitted by the transceiver to a computer with software for display. The capsule is excreted from the gut. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FFX	System, Gastrointestinal Motility (Electrical)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K881609	000

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: 7c7e7cad-a727-4d13-a414-f34f9da6337c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 03, 2017