AccessGUDID - DEVICE: Zutron Medical (00817658020164)

GUDID

Device Identifier (DI) Information

Brand Name: Zutron Medical
Version or Model: ZUTR161700
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ZUTR161700
Company Name: ZUTRON MEDICAL, L.L.C.

Primary DI Number: 00817658020164
Issuing Agency: GS1
Commercial Distribution End Date: April 29, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 962532441 *Terms of Use

Device Description: When added scope siffness is desired to negotiate a difficult colon, and prior to repositioning the patient, simply insert the Colonoscope Stiffening Device into the biopsy port to stiffen the insertion tube and advance to the cecum. The device is then withdrawn and the procedure is completed as usual. These reusable devices are compatible with Pentax ®, Fujinon®, Olympus® and Fuse® non-variable stiffness endoscopes.

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:	No
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?
17826	Colonoscope stiffener	A dedicated stiff wire that is inserted into a flexible colonoscope to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required during a colonoscopy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDF	Colonoscope And Accessories, Flexible/Rigid

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
High-level Disinfectant
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: d5c10820-c01e-44ce-934d-83539e31c44c
Public Version Date: April 30, 2024
Public Version Number: 3
DI Record Publish Date: December 01, 2016