AccessGUDID - DEVICE: wireClip™ Torquer (08714729154785)

GUDID

Device Identifier (DI) Information

Brand Name: wireClip™ Torquer
Version or Model: H802221960030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H802221960030
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729154785
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Guidewire Manipulation 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?
35094	Cardiac/peripheral vascular guidewire, single-use	A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCX	CATHETER, CORONARY, ATHERECTOMY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P900056	000
P900056	008
P900056	009
P900056	010
P900056	011
P900056	012
P900056	014
P900056	015
P900056	017
P900056	018
P900056	019
P900056	020
P900056	021
P900056	022
P900056	023
P900056	025
P900056	027
P900056	029
P900056	036
P900056	037
P900056	041
P900056	047
P900056	049
P900056	052
P900056	062
P900056	066
P900056	067
P900056	068
P900056	078
P900056	083
P900056	090
P900056	094
P900056	104
P900056	106
P900056	107

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
No Device Sizes

Device Record Status

Public Device Record Key: a73c5200-0a84-4c8a-936f-169ad0147a6f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2014