AccessGUDID - DEVICE: GRAFIX (10845854028834)

GUDID

Device Identifier (DI) Information

Brand Name: GRAFIX
Version or Model: TD8504
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: TD8504
Company Name: Conmed Corporation

Primary DI Number: 10845854028834
Issuing Agency: GS1
Commercial Distribution End Date: October 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: STERILIZATION TRAY, GRAFIX TUNNEL DILATOR SYSTEM

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?
37142	Endoscopic-access dilator, reusable	A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	TRAY, SURGICAL, INSTRUMENT

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

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bcb4c914-16e2-4c1f-8805-80053d198e9e
Public Version Date: October 05, 2023
Public Version Number: 2
DI Record Publish Date: September 24, 2020