AccessGUDID - DEVICE: CORE DYNAMICS (20653405046780)

GUDID

Device Identifier (DI) Information

Brand Name: CORE DYNAMICS
Version or Model: CD720
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CD720
Company Name: Conmed Corporation

Primary DI Number: 20653405046780
Issuing Agency: GS1
Commercial Distribution End Date: June 08, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 5-12mm CORE Seal II

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?
44096	Laparoscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.	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 [?]
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
Device Size Text, specify: 5-12 Millimeter CORE Seal II

Device Record Status

Public Device Record Key: 98c3d814-78c7-4cca-b4d5-034297f71759
Public Version Date: June 09, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016