AccessGUDID - DEVICE: Diamondback Coronary (10850000491363)

GUDID

Device Identifier (DI) Information

Brand Name: Diamondback Coronary
Version or Model: DBEC-125
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7-10060-02
Company Name: Cardiovascular Systems, Inc.

Primary DI Number: 10850000491363
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024954518 *Terms of Use

Device Description: DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT

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?
61205	Mechanical atherectomy system, coronary, line-powered	An assembly of devices intended to mechanically disrupt/remove atheroma plaque from the walls of coronary arteries. It typically includes a mains electricity (AC-powered) energy-producing generator with monitoring functions, a remote control or foot-switch, a handpiece (to which the catheter connects) and a dedicated disposable catheter with a cutting or abrasive head that transmits the mechanical energy to the atheroma. The system may include an integrated irrigation/suction system and includes/requires accessory devices for its function (e.g., saline/lubricant, pump, guidewire).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCX	Catheter, Coronary, Atherectomy

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Crown Diameter: 1.25mm
Device Size Text, specify: nose length: 5mm
Device Size Text, specify: shaft length: 135cm
Device Size Text, specify: guidewire size OD: 0.012 inches
Device Size Text, specify: low speed: 80krpm
Device Size Text, specify: high speed: 120krpm
Device Size Text, specify: Crown Type: Classic
Device Size Text, specify: Max OD: 0.052 inches
Device Size Text, specify: Intro Sheath: 6Fr

Device Record Status

Public Device Record Key: d8341452-f115-44fa-888a-e3cc1c067266
Public Version Date: December 18, 2023
Public Version Number: 2
DI Record Publish Date: March 05, 2020