Single Use Preloaded Sphincterotome V

GUDID 14953170345125

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 14953170345125
• NIH Device Record Key: ef7b0488-6f79-4f6a-a137-17c20bebcbd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Preloaded Sphincterotome V
• Version Model Number: KD-V631M-07302A
• 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
• 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	04953170345128 [Primary]
GS1	14953170345125 [Package]; Contains: 04953170345128; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122505

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-21

On-Brand Devices [Single Use Preloaded Sphincterotome V]

• 14953170403238: KD-V631M-07302A
• 14953170403221: KD-V631M-07302S
• 14953170403214: KD-V631M-07301A
• 14953170403207: KD-V631M-07301S
• 14953170403191: KD-V631M-07202A
• 14953170403184: Single Use Preloaded Sphincterotome V
• 14953170403177: KD-V631M-07201A
• 14953170403160: KD-V631M-07201S
• 14953170403153: KD-V611M-07302A
• 14953170403146: KD-V611M-07302S
• 14953170403139: KD-V611M-07301A
• 14953170403122: KD-V611M-07301S
• 14953170403115: KD-V611M-07252A
• 14953170403108: KD-V611M-07252S
• 14953170403092: KD-V611M-07251A
• 14953170403085: KD-V611M-07251S
• 14953170403078: KD-V611M-07202A
• 14953170403061: KD-V611M-07202S
• 14953170403054: KD-V611M-07201A
• 14953170403047: KD-V611M-07201S
• 14953170345125: KD-V631M-07302A
• 14953170345118: KD-V631M-07302S
• 14953170345101: KD-V631M-07301A
• 14953170345095: KD-V631M-07301S
• 14953170345088: KD-V631M-07202A
• 14953170345071: Single Use Preloaded Sphincterotome V
• 14953170345064: KD-V631M-07201A
• 14953170345057: KD-V631M-07201S
• 14953170345040: KD-V611M-07302A
• 14953170345033: KD-V611M-07302S
• 14953170345026: KD-V611M-07301A
• 14953170345019: KD-V611M-07301S
• 14953170345002: KD-V611M-07252A
• 14953170344999: KD-V611M-07252S
• 14953170344982: KD-V611M-07251A
• 14953170344975: KD-V611M-07251S
• 14953170344968: KD-V611M-07202A
• 14953170344951: KD-V611M-07202S
• 14953170344944: KD-V611M-07201A
• 14953170344937: KD-V611M-07201S