CROSPERIO OTW BD-B35150LW

GUDID 04540778165137

CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wi

KANEKA CORPORATION

Peripheral angioplasty balloon catheter, basic
Primary Device ID04540778165137
NIH Device Record Key4f590861-5356-4213-a712-87ab5a6c0eaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameCROSPERIO OTW
Version Model NumberBD-B35150LW
Catalog NumberBD-B35150LW
Company DUNS690535406
Company NameKANEKA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-888-3786
Emailtmccustomer.admin@terumomedica

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry, dark place. Avoid exposure to water, direct sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS104540778165137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, Angioplasty, Peripheral, Transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-26

On-Brand Devices [CROSPERIO OTW]

04540778165250CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778165236CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778165212CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778165199CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778165175CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778165151CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778165137CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778165113CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778165090CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778165076CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778165052CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778165038CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778165014CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164994CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164970CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164956CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164932CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164918CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164895CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164871CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164857CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164833CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164819CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164796CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164772CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164758CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164734CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164710CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164697CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164673CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164659CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164635CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164611CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164598CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164574CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164550CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164536CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164512CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164499CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164475CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164451CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164437CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164413CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164390CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164376CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164352CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164338CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164314CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164291CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778164277CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p

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