Olympus

GUDID 04953170022784

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic irrigation/distension bottle

• Primary Device ID: 04953170022784
• NIH Device Record Key: 90c04843-226a-4837-9c8e-acd03525698d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olympus
• Version Model Number: MAJ-526
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170022784 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982289

FDA Product Code

• KNS: Unit, electrosurgical, endoscopic (with or without accessories)

Sterilization

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

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

[04953170022784]

High-level Disinfectant;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-09-21

On-Brand Devices [Olympus]

• 14953170409681: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S
• 14953170409674: THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S
• 14953170408295: Single Use Biopsy Forceps FB-245U
• 14953170408288: Single Use Biopsy Forceps FB-235U
• 14953170408271: Single Use Biopsy Forceps FB-225U
• 14953170408264: Single Use Biopsy Forceps FB-215U
• 14953170402644: Single Use Aspiration Needle NA-U201H
• 14953170402620: Single Use Aspiration Needle NA-U201H
• 14953170402606: Single Use Aspiration Needle NA-U201H
• 14953170402583: Single Use Aspiration Needle NA-U201H
• 14953170402569: Single Use Aspiration Needle NA-U201H
• 14953170402545: Single Use Aspiration Needle NA-U201H
• 04953170402456: OLYMPUS ENF-V4
• 04953170402425: OLYMPUS ENF-VH2
• 14953170401074: Single Use Surgical Scissors FS-200
• 14953170401050: Single Use Loop Cutter FS-410
• 14953170401036: Single Use Loop Cutter FS-410
• 14953170399531: Single Use Preloaded Sphincterotome V(Distal Wireguided)
• 14953170399524: Single Use Preloaded Sphincterotome V(Distal Wireguided)
• 14953170399517: Single Use Preloaded Sphincterotome V(Distal Wireguided)
• 14953170399500: Single Use Preloaded Sphincterotome V(Distal Wireguided)
• 14953170399494: Single Use Preloaded Sphincterotome V (Distal Wireguided)
• 14953170399487: Single Use Preloaded Sphincterotome V (Distal Wireguided)
• 14953170399470: Single Use Preloaded Sphincterotome V (Distal Wireguided)
• 14953170399463: Single Use Preloaded Sphincterotome V (Distal Wireguided)
• 14953170399456: Single Use Preloaded Sphincterotome V(Distal Wireguided)
• 14953170399449: Single Use Preloaded Sphincterotome V(Distal Wireguided)
• 14953170399432: Single Use Preloaded Sphincterotome V(Distal Wireguided)
• 14953170399425: Single Use Preloaded Sphincterotome V(Distal Wireguided)
• 14953170399418: Single Use Preloaded Sphincterotome V (Distal Wireguided)
• 14953170399401: Single Use Preloaded Sphincterotome V (Distal Wireguided)
• 14953170399395: Single Use Preloaded Sphincterotome V (Distal Wireguided)
• 14953170399388: Single Use Preloaded Sphincterotome V (Distal Wireguided)
• 14953170399371: Single Use Sphincterotome V
• 14953170399364: Single Use Sphincterotome V
• 14953170399357: Single Use Sphincterotome V (Distal Wireguided)
• 14953170399340: Single Use Sphincterotome V(Distal Wireguided)
• 14953170399333: Single Use Sphincterotome V(Distal Wireguided)
• 14953170399326: Single Use Sphincterotome V(Distal Wireguided)
• 14953170399319: Single Use Sphincterotome V(Distal Wireguided)
• 14953170399302: Single Use Sphincterotome V(Distal Wireguided)
• 14953170399296: Single Use Sphincterotome V(Distal Wireguided)
• 04953170399282: RHINO-LARYNGO FIBERSCOPE ENF-GP2
• 14953170392235: THUNDERBEAT 5mm, 20cm, Front-actuated Grip Type X
• 14953170392228: THUNDERBEAT 5mm, 20cm, Front-actuated Grip Type X
• 14953170392204: THUNDERBEAT 5mm, 35cm, Front-actuated Grip Type X
• 14953170392198: THUNDERBEAT 5mm, 35cm, Front-actuated Grip Type X
• 14953170392174: THUNDERBEAT 5mm, 45cm, Front-actuated Grip Type X
• 14953170392167: THUNDERBEAT 5mm, 45cm, Front-actuated Grip Type X
• 04953170391965: INTERFACE FOR OLYMPUS LINK DEVICE