HOT BIOPSY FORCEPS

GUDID 14953170035415

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible endoscopic biopsy forceps, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: 14953170035415
• NIH Device Record Key: a785b5ae-5d4c-4526-8c7b-297b345b6642
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOT BIOPSY FORCEPS
• Version Model Number: FD-1L-1
• 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: 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	04953170035418 [Primary]
GS1	14953170035415 [Package]; Contains: 04953170035418; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062517

FDA Product Code

• KGE: FORCEPS, BIOPSY, ELECTRIC

Sterilization

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

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

[14953170035415]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

On-Brand Devices [HOT BIOPSY FORCEPS]

• 04953170355288: FD-6C-1
• 14953170035453: FD-1U-1.B HOT BIOP FRCPS
• 14953170035415: FD-1L-1
• 04953170060748: FD-6C-1