CROSSTELLA RX BD-F60150LR

GUDID 04540778159358

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

KANEKA CORPORATION

Peripheral angioplasty balloon catheter, basic
Primary Device ID04540778159358
NIH Device Record Key38d5fa80-0e97-4ee0-a2b9-0a6dc2dc0590
Commercial Distribution StatusIn Commercial Distribution
Brand NameCROSSTELLA RX
Version Model NumberBD-F60150LR
Catalog NumberBD-F60150LR
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
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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
GS104540778159358 [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 [CROSSTELLA RX]

04540778160439CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160415CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160392CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160378CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160354CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160330CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160316CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160293CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160279CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160255CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160231CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160217CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160194CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160170CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160156CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160132CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160118CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160095CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160071CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160057CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160033CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778160019CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159990CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159976CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159952CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159938CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159914CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159891CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159877CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159853CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159839CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159815CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159792CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159778CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159754CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159730CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159716CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159693CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159679CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159655CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159631CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159617CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159594CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159570CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159556CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159532CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159518CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159495CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159471CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p
04540778159457CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for p

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