AccessGUDID - DEVICE: KEYPORT (04055207021071)

GUDID

Device Identifier (DI) Information

Brand Name: KEYPORT
Version or Model: 8850243
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8850243
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207021071
Issuing Agency: GS1
Commercial Distribution End Date: May 24, 2020
Device Count: 3
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: SILICONE SEALING INSERT with three valve accesses, PACK=3 PCS, with connection for CO2 insufflation / smoke aspiration, 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:	No
Prescription Use (Rx):	No
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?
62452	Laparoscopic multi-instrument access port, reusable	A multi-lumen sleeve assembly intended to retract a small abdominal incision to allow multiple laparoscopic instruments to access the abdominal cavity simultaneously through a single abdominal incision, during minimally-invasive laparoscopic surgery. It will include a valve component for each lumen that maintains the established pneumoperitoneum; the trocar used to create the abdominal incision might be included; it may include attached external instrument holding arms. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OTJ	Laparoscopic single port access device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: e88d787b-813d-4837-801e-22530acf765b
Public Version Date: May 26, 2023
Public Version Number: 7
DI Record Publish Date: September 26, 2016