AccessGUDID - DEVICE: YelloPort Plus - Laparoscopic Port Access System (05051986002361)

GUDID

Device Identifier (DI) Information

Brand Name: YelloPort Plus - Laparoscopic Port Access System
Version or Model: YA05VSS02
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SURGICAL INNOVATIONS LIMITED

Primary DI Number: 05051986002361
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 771051935 *Terms of Use

Device Description: 5mm Single Use Duckbill Valve QTY 2

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?
45645	Laparoscopic access cannula seal, single-use	A small, sterile device intended to create a seal between a laparoscopic access cannula (not included) and an appropriately sized laparoscopic instrument, to inhibit the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. 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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070712	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 759a6a92-74cf-4428-b0b0-d472dba0bca7
Public Version Date: March 30, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2016