AccessGUDID - DEVICE: ROTAPRO™ (08714729999560)

GUDID

Device Identifier (DI) Information

Brand Name: ROTAPRO™
Version or Model: H749394671250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H749394671250
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729999560
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device

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 [?]
P900056	181

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
Guidewire Diameter: 1.25 Millimeter

Device Record Status

Public Device Record Key: 5bb9eb9a-c2e6-4f16-9805-90bce3b60757
Public Version Date: April 06, 2021
Public Version Number: 2
DI Record Publish Date: July 01, 2020