AccessGUDID - DEVICE: symphonX™ (08719324463188)

GUDID

Device Identifier (DI) Information

Brand Name: symphonX™
Version or Model: Introducer Clamp Type A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 314-102
Company Name: Fortimedix Surgical B.V.

Primary DI Number: 08719324463188
Issuing Agency: GS1
Commercial Distribution End Date: September 10, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 492888563 *Terms of Use

Device Description: The symphonX™ Introducer Clamp is to fix / snug fit lock the symphonX™ Introducer to the trocar in axial direction during surgery.

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):	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?
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
Storage Environment Temperature: between 5 and 45 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 62d073aa-4e2b-4031-9c53-dc67a3cdf8c2
Public Version Date: September 14, 2020
Public Version Number: 4
DI Record Publish Date: May 22, 2019