GUDID 08714729005544

Amplatz Type Renal Dilator

BOSTON SCIENTIFIC CORPORATION

Multi-purpose percutaneous drainage catheter
Primary Device ID08714729005544
NIH Device Record Key7583acdb-c55b-456d-8761-06dff78f164b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberM0062601120
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
GS108714729005544 [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

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00191506046347 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter
00191506046354 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter
00191506046361 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter
00191506046378 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter
00191506046385 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter
00191506046392 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter
00191506046408 - Sterling™2025-03-31 PTA Balloon Dilatation Catheter

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