Sapphire II Pro

GUDID 06934955942051

Balloon Dilatation Catheter

OrbusNeich Medical (ShenZhen) Co., Ltd.

Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Coronary angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic
Primary Device ID06934955942051
NIH Device Record Keyb69304c9-19e7-41c5-b120-e3f765118cc7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSapphire II Pro
Version Model Number212-053-5UU
Company DUNS530923226
Company NameOrbusNeich Medical (ShenZhen) Co., Ltd.
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 Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone954-730-0711
Emailjpazienza@orbusneich.com
Phone954-730-0711
Emailjpazienza@orbusneich.com
Phone954-730-0711
Emailjpazienza@orbusneich.com
Phone954-730-0711
Emailjpazienza@orbusneich.com
Phone954-730-0711
Emailjpazienza@orbusneich.com
Phone954-730-0711
Emailjpazienza@orbusneich.com
Phone954-730-0711
Emailjpazienza@orbusneich.com
Phone954-730-0711
Emailjpazienza@orbusneich.com
Phone954-730-0711
Emailjpazienza@orbusneich.com
Phone954-730-0711
Emailjpazienza@orbusneich.com
Phone954-730-0711
Emailjpazienza@orbusneich.com
Phone954-730-0711
Emailjpazienza@orbusneich.com
Phone954-730-0711
Emailjpazienza@orbusneich.com
Phone954-730-0711
Emailjpazienza@orbusneich.com

Device Dimensions

Length5 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter
Outer Diameter1.25 Millimeter
Length5 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.

Device Identifiers

Device Issuing AgencyDevice ID
GS106934955942051 [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 Number6
Public Version Date2019-10-07
Device Publish Date2018-03-09

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06934955942327Balloon Dilatation Catheter
06934955942310Balloon Dilatation Catheter
06934955942303Balloon Dilatation Catheter
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06934955942099Balloon Dilatation Catheter
06934955942082Balloon Dilatation Catheter
06934955942075Balloon Dilatation Catheter
06934955942068Balloon Dilatation Catheter
06934955942051Balloon Dilatation Catheter
06934955942044Balloon Dilatation Catheter
06934955942037Balloon Dilatation Catheter
06934955942020Balloon Dilatation Catheter
06934955942013Balloon Dilatation Catheter
06934955942150Balloon Dilatation Catheter
06934955942143Balloon Dilatation Catheter
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