AccessGUDID - DEVICE: CORE DYNAMICS (20653405046162)

GUDID

Device Identifier (DI) Information

Brand Name: CORE DYNAMICS
Version or Model: CD775
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CD775
Company Name: Conmed Corporation

Primary DI Number: 20653405046162
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 5-12mm ENTREE Valve/Reducer

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
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
Device Size Text, specify: 5-12 Millimeter Outer Diameter ENTREE II Cannula Valve

Device Record Status

Public Device Record Key: e24a7faa-3a85-40d0-938d-02c90c2dc43c
Public Version Date: July 25, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10653405046165	10	20653405046162		In Commercial Distribution	BOX

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00653405046168 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)237-0169
Email: CUSTOMER_SERVICE@CONMED.COM

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES