Sapphire NC Plus

GUDID 06934955916823

Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter

OrbusNeich Medical (ShenZhen) Co., Ltd.

Coronary angioplasty balloon catheter, basic
Primary Device ID06934955916823
NIH Device Record Key3024e9ab-67e0-483a-8c88-7f45ff2f2166
Commercial Distribution StatusIn Commercial Distribution
Brand NameSapphire NC Plus
Version Model Number235-103-2U
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

Device Dimensions

Outer Diameter3.5 Millimeter
Outer Diameter3.5 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS106934955916823 [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 Number5
Public Version Date2019-10-07
Device Publish Date2018-01-19

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06934955916946Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916939Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916922Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
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06934955916908Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916892Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916885Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916878Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916861Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
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06934955916847Percutaneous Transluminal Coronary Angioplasty (PTCA) BalloonCatheter
06934955916830Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916823Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916816Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916809Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916793Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916786Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916779Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916762Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916755Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916748Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916731Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916724Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916717Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916700Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916694Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916687Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916670Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916663Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916656Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916649Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916632Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916625Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916618Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916601Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916595Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955916588Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
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06934955916564Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
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06934955934650Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955934643Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955934636Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955934629Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter
06934955934612Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter

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