AccessGUDID - DEVICE: NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter (B227NRP1303)

GUDID

Device Identifier (DI) Information

Brand Name: NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter
Version or Model: R-420-159
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R-420-159
Company Name: NORTH EAST SCIENTIFIC INC

Primary DI Number: B227NRP1303
Issuing Agency: HIBCC
Commercial Distribution End Date: November 24, 2030
Device Count: 1
Labeler D-U-N-S® Number*: 608625823 *Terms of Use

Device Description: No description.

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?
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
QTF	Reprocessed Atherectomy Catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 588b5e22-0586-41a3-84fc-45332a3b9511
Public Version Date: September 25, 2023
Public Version Number: 1
DI Record Publish Date: September 15, 2023