Single Use Biliary Stent V

GUDID 14953170185554

OLYMPUS MEDICAL SYSTEMS CORP.

Biliary drainage catheter

• Primary Device ID: 14953170185554
• NIH Device Record Key: be91c21f-3f1c-41d3-883a-b30fa7bd7a46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Biliary Stent V
• Version Model Number: PBD-200-0809
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170185557 [Primary]
GS1	14953170185554 [Package]; Contains: 04953170185557; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933200

FDA Product Code

• FGE: CATHETER, BILIARY, DIAGNOSTIC

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: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [Single Use Biliary Stent V]

• 14953170186414: Single Use Biliary Stent V
• 14953170186391: Single Use Biliary Stent V
• 14953170186377: Single Use Biliary Stent V
• 14953170186353: Single Use Biliary Stent V
• 14953170186339: PBD-203-0703
• 14953170186315: Single Use Biliary Stent V
• 14953170186292: Single Use Biliary Stent V
• 14953170186278: Single Use Biliary Stent V
• 14953170186254: Single Use Biliary Stent V
• 14953170186230: Single Use Biliary Stent V
• 14953170186216: PBD-202-0815
• 14953170186193: PBD-202-0812
• 14953170186179: PBD-202-0809
• 14953170186155: PBD-202-0807
• 14953170186131: PBD-202-0805
• 14953170186117: Single Use Biliary Stent V
• 14953170186094: Single Use Biliary Stent V
• 14953170186070: Single Use Biliary Stent V
• 14953170186056: Single Use Biliary Stent V
• 14953170186032: Single Use Biliary Stent V
• 14953170186018: Single Use Biliary Stent V
• 14953170185998: Single Use Biliary Stent V
• 14953170185974: Single Use Biliary Stent V
• 14953170185950: Single Use Biliary Stent V
• 14953170185936: Single Use Biliary Stent V
• 14953170185912: PBD-201-0815
• 14953170185899: Single Use Biliary Stent V
• 14953170185875: Single Use Biliary Stent V
• 14953170185851: Single Use Biliary Stent V
• 14953170185837: Single Use Biliary Stent V
• 14953170185813: Single Use Biliary Stent V
• 14953170185790: Single Use Biliary Stent V
• 14953170185776: Single Use Biliary Stent V
• 14953170185752: Single Use Biliary Stent V
• 14953170185738: Single Use Biliary Stent V
• 14953170185714: PBD-200-1015
• 14953170185691: PBD-200-1012
• 14953170185677: PBD-200-1009
• 14953170185653: PBD-200-1007
• 14953170185639: Single Use Biliary Stent V
• 14953170185615: PBD-200-1003
• 14953170185592: PBD-200-0815
• 14953170185578: PBD-200-0812
• 14953170185554: PBD-200-0809
• 14953170185530: PBD-200-0807
• 14953170185516: PBD-200-0805
• 14953170185493: PBD-200-0803
• 14953170185479: PBD-200-0715
• 14953170185455: PBD-200-0712
• 14953170185431: PBD-200-0709