AccessGUDID - DEVICE: CORE DYNAMICS (20653405045707)

GUDID

Device Identifier (DI) Information

Brand Name: CORE DYNAMICS
Version or Model: CD405
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CD405
Company Name: Conmed Corporation

Primary DI Number: 20653405045707
Issuing Agency: GS1
Commercial Distribution End Date: June 06, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 5/5.5mm Fascia Anchor Adapter for Entree® Plus and Entree® II Cannula, 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?
61699	Laparoscopic access cannula anchor, reusable	A small, luminal device designed to enable a laparoscopic access cannula (port) to be secured to the skin/tissue of an incision site during a laparoscopic surgical procedure. The outer surface is typically textured/ribbed and intended to grip the tissue whilst the laparoscopic access cannula is inserted through the device lumen and fixed at the required insertion depth using a clamping mechanism. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FBM	Cannula and trocar, suprapubic, non-disposable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K932021	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
Device Size Text, specify: 5/5.5 Millimeter Fascia Anchor Adaptor for ENTREE Plus and ENTREE II Cannula

Device Record Status

Public Device Record Key: 8243fdb0-4a6b-43e3-aedc-d68def330954
Public Version Date: June 07, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016