RFS Disposable Pin Applicator RFS-PA15

GUDID E302RFSPA159

RFS™ Disposable Pin Applicator 1.5mm

Bioretec Oy

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: E302RFSPA159
• NIH Device Record Key: 13d671e1-5206-4a85-81eb-ebc647ec57c6
• Commercial Distribution Discontinuation: 2017-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RFS Disposable Pin Applicator
• Version Model Number: RFS-PA15
• Catalog Number: RFS-PA15
• Company DUNS: 368715301
• Company Name: Bioretec Oy
• 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: true
• Expiration Date: true
• 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: +358207789500
• Email: sales@bioretec.com

Device Dimensions

• Width: 1.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E302RFSPA159 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080879

FDA Product Code

• HTY: Pin, Fixation, Smooth

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: 2016-08-22

On-Brand Devices [RFS Disposable Pin Applicator]

• E302RFSPA279: RFS™ Disposable Pin Applicator 2.7mm
• E302RFSPA209: RFS™ Disposable Pin Applicator 2.0mm
• E302RFSPA159: RFS™ Disposable Pin Applicator 1.5mm