AccessGUDID - DEVICE: ST MARKS FISTULA PROBE (00192896044609)

GUDID

Device Identifier (DI) Information

Brand Name: ST MARKS FISTULA PROBE
Version or Model: 508-541
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 508-541
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896044609
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: ST MARKS FISTULA PROBE CURVED SHAFT

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:	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?
46486	Gastro-urological director	A slender, rod-like surgical instrument made of metal, typically with groove running along the centre of it distal shaft and/or continuing with an elongated malleable wire loop, that is used to guide other devices or instruments into a selected intracorporeal location during a gastroenterological/urological (GU) procedure. The distal shaft may be straight or curved and the proximal handle formed as a finger grip. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGM	Probe And Director, Gastro-Urology

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
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 7 Inch

Device Record Status

Public Device Record Key: aad9e490-4645-4800-b1dc-a3d7f532cc72
Public Version Date: March 25, 2024
Public Version Number: 3
DI Record Publish Date: September 14, 2018