AccessGUDID - DEVICE: Optical Separator® System (00607915114077)

GUDID

Device Identifier (DI) Information

Brand Name: Optical Separator® System
Version or Model: C0125
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: APPLIED MEDICAL RESOURCES CORPORATION

Primary DI Number: 00607915114077
Issuing Agency: GS1
Commercial Distribution End Date: November 06, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 187129135 *Terms of Use

Device Description: Optical Separator Trocar

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?
42412	Laparoscopic access cannula, single-use	A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 150 Millimeter
Lumen/Inner Diameter: 12 Millimeter

Device Record Status

Public Device Record Key: b055bfd3-e79c-4bee-9a45-3d073f28e101
Public Version Date: January 09, 2020
Public Version Number: 4
DI Record Publish Date: August 25, 2016