Sapphire II Pro

GUDID 06934955942181

Balloon Dilatation Catheter

OrbusNeich Medical (ShenZhen) Co., Ltd.

Coronary angioplasty balloon catheter, basic
Primary Device ID06934955942181
NIH Device Record Key8bf851d4-bd9f-426c-bf2c-da65a0e99e45
Commercial Distribution StatusIn Commercial Distribution
Brand NameSapphire II Pro
Version Model Number220-153-5UU
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

Length15 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 Millimeter
Outer Diameter2 Millimeter
Length15 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
GS106934955942181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-10-07
Device Publish Date2018-01-19

On-Brand Devices [Sapphire II Pro]

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06934955942440Balloon Dilatation Catheter
06934955942433Balloon Dilatation Catheter
06934955942426Balloon Dilatation Catheter
06934955942419Balloon Dilatation Catheter
06934955942402Balloon Dilatation Catheter
06934955942396Balloon Dilatation Catheter
06934955942389Balloon Dilatation Catheter
06934955942372Balloon Dilatation Catheter
06934955942365Balloon Dilatation Catheter
06934955942358Balloon Dilatation Catheter
06934955942341Balloon Dilatation Catheter
06934955942334Balloon Dilatation Catheter
06934955942327Balloon Dilatation Catheter
06934955942310Balloon Dilatation Catheter
06934955942303Balloon Dilatation Catheter
06934955942297Balloon Dilatation Catheter
06934955942280Balloon Dilatation Catheter
06934955942273Balloon Dilatation Catheter
06934955942266Balloon Dilatation Catheter
06934955942259Balloon Dilatation Datheter
06934955942242Balloon Dilatation Catheter
06934955942235Balloon Dilatation Catheter
06934955942228Balloon Dilatation Catheter
06934955942211Balloon Dilatation Catheter
06934955942204Balloon Dilatation Catheter
06934955942198Balloon Dilatation Catheter
06934955942181Balloon Dilatation Catheter
06934955942174Balloon Dilatation Catheter
06934955942167Balloon Dilatation Catheter
06934955942136Balloon Dilatation Catheter
06934955942129Balloon Dilatation Catheter
06934955942112Balloon Dilatation Catheter
06934955942105Balloon Dilatation Catheter
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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