AccessGUDID - DEVICE: CORE DYNAMICS (20653405045455)

GUDID

Device Identifier (DI) Information

Brand Name: CORE DYNAMICS
Version or Model: CD225
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CD225
Company Name: Conmed Corporation

Primary DI Number: 20653405045455
Issuing Agency: GS1
Commercial Distribution End Date: June 08, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 10/12mm Cannula Obturator Rod for Choangiogram, Reusable

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
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953903	000

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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: .833 Millimeter

Device Record Status

Public Device Record Key: dc9f3e6e-4207-4c58-8930-a0ab2b10de86
Public Version Date: June 09, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016