R2P METACROSS RX BD-P70100ER

GUDID 04540778166851

R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P METACROSS RX is a rapid

KANEKA CORPORATION

Peripheral angioplasty balloon catheter, basic
Primary Device ID04540778166851
NIH Device Record Key4e257bf2-c4ae-40ba-86a4-cd419876e1ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameR2P METACROSS RX
Version Model NumberBD-P70100ER
Catalog NumberBD-P70100ER
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
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
GS104540778166851 [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 Date2017-06-01

On-Brand Devices [R2P METACROSS RX]

04540778167155R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778167131R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778167117R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778167094R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778167070R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778167056R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778167032R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778167018R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166998R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166974R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166950R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166936R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166912R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166899R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166875R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166851R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166837R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166813R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166790R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166776R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166752R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166738R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166714R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166691R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166677R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166653R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166639R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166615R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166592R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166578R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166554R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166530R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166516R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166493R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166479R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166455R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166431R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166417R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166394R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166370R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166356R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166332R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166318R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo
04540778166295R2P METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter fo

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.