AccessGUDID - DEVICE: CORE DYNAMICS (20653405044564)

GUDID

Device Identifier (DI) Information

Brand Name: CORE DYNAMICS
Version or Model: CD112B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CD112B
Company Name: Conmed Corporation

Primary DI Number: 20653405044564
Issuing Agency: GS1
Commercial Distribution End Date: June 08, 2022
Device Count: 20
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 10/12mm Sealing Cap for Entree® Pies Cannula and Reducer Sleeves, 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:	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?
61713	Laparoscopic access cannula seal, reusable	A small, noninvasive device intended to be fitted into the proximal end of a laparoscopic access cannula to create a seal between the cannula and an introduced laparoscopic instrument, for inhibition of insufflation gas leakage. It is intended to be fitted directly to the proximal end of the sleeve and is typically available in a variety of sizes appropriate for given sleeve/instrument diameters. 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 [?]
K911813	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
No Device Sizes

Device Record Status

Public Device Record Key: 8db086e9-0cda-4ef2-ae80-d66515607186
Public Version Date: July 25, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2016