AccessGUDID - DEVICE: symphonX™ (08719324463324)

GUDID

Device Identifier (DI) Information

Brand Name: symphonX™
Version or Model: Maryland short
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 314-008
Company Name: Fortimedix Surgical B.V.

Primary DI Number: 08719324463324
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: Device for grasping and dissecting tissue; to be used in combination with the symphonX Handle, Handle with ratchet, Handle with on/off ratchet.

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?
47415	Laparoscopic blunt dissector	A sterile, rigid, manual instrument designed to facilitate blunt dissection between tissue planes during laparoscopic procedures, and may additionally be used during open surgical interventions of the abdomen. It is typically made of high-grade stainless steel and plastic materials, and usually consists of a long, thin shaft with a handle and activation lever proximally, and distally a steerable, flexible blunt tip used to mechanically disrupt tissues. Using the lever, the operator can articulate and lock the tip at an angle. It may also be used to snare and pull a pre-tied suture or interface with other similarly shaped articles (e.g., gastric band tubing). 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 [?]
Premarket Submission Number Not Available/Not Released

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
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: 47366067-ff11-4aea-8c0f-a108c15f61f5
Public Version Date: September 14, 2020
Public Version Number: 8
DI Record Publish Date: August 25, 2017