AccessGUDID - DEVICE: CVX-300®-P (M204CVX300PAA0)

GUDID

Device Identifier (DI) Information

Brand Name: CVX-300®-P
Version or Model: CVX300P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CVX300P
Company Name: Spectranetics Corporation

Primary DI Number: M204CVX300PAA0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 151047370 *Terms of Use

Device Description: Excimer Laser System

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:	No
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?
60389	Atherectomy excimer laser system	A mobile, mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite dimers (typically rare gas monohalides such as argon fluoride, xenon chloride) as the active medium to emit a beam of intense, coherent, monochromatic, electromagnetic (EM) radiation intended for the intraluminal photoablation or debulking of vascular lesion material (blockages, total occlusions) and sometimes to photoablate tissue attached to the leads of active implantable devices. It is intended to be used with an angioplasty catheter and typically consists of an electrical unit with a display, controls and/or foot-switch.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LPC	Device, Angioplasty, Laser, Coronary

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: No
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: b149d563-f4b7-4444-94ca-39169dbad109
Public Version Date: October 26, 2021
Public Version Number: 5
DI Record Publish Date: January 20, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-800-633-0960
Email: complaints@spnc.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES