ERCP

GUDID 00857834006094

HERAEUS MEDICAL COMPONENTS, LLC

Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use Gastro-urological guidewire, single-use

• Primary Device ID: 00857834006094
• NIH Device Record Key: bd615e0d-a07e-40ea-ac0e-3e1210e40c43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERCP
• Version Model Number: GI103
• Company DUNS: 080645456
• Company Name: HERAEUS MEDICAL COMPONENTS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857834006094 [Primary]

FDA Product Code

• OCY: Endoscopic Guidewire, Gastroenterology-Urology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-05
• Device Publish Date: 2016-09-21

On-Brand Devices [ERCP]

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