AccessGUDID - DEVICE: CORE DYNAMICS (20653405045684)

GUDID

Device Identifier (DI) Information

Brand Name: CORE DYNAMICS
Version or Model: CD4011P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CD4011P
Company Name: Conmed Corporation

Primary DI Number: 20653405045684
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 10mm ENTREE® Plus Trocar

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:	Yes
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?
61425	Laparoscopic trocar blade, single-use	A rigid surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HET	LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K950457	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 10 Millimeter
Length: 110 Meter

Device Record Status

Public Device Record Key: b8fe3175-bce8-4eda-bd9b-198b8c675fac
Public Version Date: June 08, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2016