AccessGUDID - DEVICE: Turbo Tandem™ (M2044721100)

GUDID

Device Identifier (DI) Information

Brand Name: Turbo Tandem™
Version or Model: 472-110
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 472-110
Company Name: Spectranetics Corporation

Primary DI Number: M2044721100
Issuing Agency: HIBCC
Commercial Distribution End Date: February 06, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 151047370 *Terms of Use

Device Description: Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter

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:	Yes
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?
43229	Atherectomy laser system beam guide-catheter, peripheral	A sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), to re-establish blood flow within the vessel. It typically consists of fibreoptic materials with a laser-firing distal end and may be designed for over-the-wire (OTW) or rapid exchange insertion. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCW	Catheter, Peripheral, Atherectomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K094036	000
K140775	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 110 Centimeter

Device Record Status

Public Device Record Key: 8616dbd1-7518-4bb8-ac9e-7c5111eb58d8
Public Version Date: October 26, 2021
Public Version Number: 5
DI Record Publish Date: August 19, 2014