GUDID 08714729005513

Amplatz Type Renal Dilator

BOSTON SCIENTIFIC CORPORATION

Multi-purpose percutaneous drainage catheter
Primary Device ID08714729005513
NIH Device Record Key2c8e1d05-207d-457a-ba03-5af455091a7e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberM0062601090
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS108714729005513 [Primary]

FDA Product Code

GCCDilator, catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-11
Device Publish Date2016-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

08714729269915 - Electrophysiology Cable2025-01-15 Sterile Cable
08714729877868 - Radia™2025-01-08 Bidirectional Steerable Diagnostic Catheter
08714729877875 - Radia™2025-01-08 Bidirectional Steerable Diagnostic Catheter
08714729877882 - Radia™2025-01-08 Bidirectional Steerable Diagnostic Catheter
08714729877899 - Radia™2025-01-08 Bidirectional Steerable Diagnostic Catheter
08714729877905 - Radia™2025-01-08 Bidirectional Steerable Diagnostic Catheter
08714729877912 - Radia™2025-01-08 Bidirectional Steerable Diagnostic Catheter
08714729877929 - Radia™2025-01-08 Bidirectional Steerable Diagnostic Catheter

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