AccessGUDID - DEVICE: Coil Pusher-16 (08714729158967)

GUDID

Device Identifier (DI) Information

Brand Name: Coil Pusher-16
Version or Model: M0014012160
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M0014012160
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 08714729158967
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Coil Pusher-16

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?
43978	Embolization implant inserter	A long, thin, manual surgical device intended to advance an embolization implant (e.g. an embolic coil) through the length of an appropriate catheter so that the implant is ready for discharge (implantation) when the catheter has been surgically positioned at the target site in an artery or vein. The inserter, also known as a pusher, is removed prior to discharge of the implant. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRD	Device, Vascular, for Promoting Embolization

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 0.016 in Diameter
Device Size Text, specify: 0.41 mm Diameter
Device Size Text, specify: 177 cm Length

Device Record Status

Public Device Record Key: c084bbaa-af78-47c6-a584-252b27e4d30f
Public Version Date: June 10, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2015