Wolverine Coronary Cutting Balloon H74939401062500

GUDID 08714729888154

Microsurgical Dilatation Device

BOSTON SCIENTIFIC CORPORATION

Coronary angioplasty balloon catheter, cutting/scoring

Primary Device ID	08714729888154
NIH Device Record Key	5492e69e-797b-4c04-b6be-709f629fefa5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Wolverine Coronary Cutting Balloon
Version Model Number	H74939401062500
Catalog Number	H74939401062500
Company DUNS	021717889
Company Name	BOSTON SCIENTIFIC CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729888154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P950020

FDA Product Code

NWX	Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2022-05-13
Device Publish Date	2017-11-22

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