ERCP

GUDID 00857834006322

HERAEUS MEDICAL COMPONENTS, LLC

Gastro-urological guidewire, single-use
Primary Device ID00857834006322
NIH Device Record Keyf59af24f-9d4e-4c6b-89a1-bee2fe3f8a75
Commercial Distribution StatusIn Commercial Distribution
Brand NameERCP
Version Model NumberGI126
Company DUNS080645456
Company NameHERAEUS MEDICAL COMPONENTS, LLC
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857834006322 [Primary]

FDA Product Code

OCYEndoscopic Guidewire, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-10-05
Device Publish Date2016-09-21

On-Brand Devices [ERCP]

00857834006384GI132
00857834006377GI131
00857834006360GI130
00857834006353GI129
00857834006346GI128
00857834006339GI127
00857834006322GI126
00857834006315GI125
00857834006308GI124
00857834006292GI123
00857834006285GI122
00857834006278GI121
00857834006261GI120
00857834006254GI119
00857834006247GI118
00857834006230GI117
00857834006223GI116
00857834006216GI115
00857834006209GI114
00857834006193GI113
00857834006186GI112
00857834006179GI111
00857834006162GI110
00857834006155GI109
00857834006148GI108
00857834006131GI107
00857834006124GI106
00857834006117GI105
00857834006100GI104
00857834006094GI103
00857834006087GI102
00857834006070GI101

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