AccessGUDID - DEVICE: Trimedyne® R-50™ Spinal Introduction Cannula (M473700520)

GUDID

Device Identifier (DI) Information

Brand Name: Trimedyne® R-50™ Spinal Introduction Cannula
Version or Model: 70052
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70052
Company Name: TRIMEDYNE, INC.

Primary DI Number: M473700520
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 057007239 *Terms of Use

Device Description: Introducer, Spine, 1.75mm ID

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?
58752	Arthroscopic access cannula, single-use	A single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)

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
No Device Sizes

Device Record Status

Public Device Record Key: f88183fe-ceb5-4f2e-bda9-77266d59670c
Public Version Date: February 27, 2020
Public Version Number: 3
DI Record Publish Date: July 11, 2018