AccessGUDID - DEVICE: CORE DYNAMICS (20653405044946)

GUDID

Device Identifier (DI) Information

Brand Name: CORE DYNAMICS
Version or Model: CD153
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CD153
Company Name: Conmed Corporation

Primary DI Number: 20653405044946
Issuing Agency: GS1
Commercial Distribution End Date: March 30, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 5.5mm w/3mm Hole Sealing Cap

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?
45597	Laparoscopic access cannula seal reducer, single-use	A small device intended to reduce the sealing diameter of an existing laparoscopic access cannula seal, so laparoscopic instruments with smaller diameters can be introduced through the parent laparoscopic sleeve whilst maintaining a seal and inhibiting the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to fit within the laparoscopic access cannula seal (fitted at the proximal end of the cannula) when required throughout the laparoscopic surgical procedure. 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 [?]
K911813	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: 3 MILLIMETER
Device Size Text, specify: 5.5 MILLIMETER

Device Record Status

Public Device Record Key: 8550ee98-5317-45cc-822b-5924a5096312
Public Version Date: July 25, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2016