Disposable Pin Applicator B-DIP-3200

GUDID E302BDIP32009

Applicator with K-Wire Ø3.2 mm, disposable,for 3.2 mm pins

Bioretec Oy

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

• Primary Device ID: E302BDIP32009
• NIH Device Record Key: e62899e6-7331-4ad8-aad3-ebb05bed7ccc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Pin Applicator
• Version Model Number: B-DIP-3200
• Catalog Number: B-DIP-3200
• 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: 3.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E302BDIP32009 [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 [Disposable Pin Applicator]

• E302BDIP32009: Applicator with K-Wire Ø3.2 mm, disposable,for 3.2 mm pins
• E302BDIP27009: Applicator with K-Wire Ø2.8 mm, disposable, for 2.7 mm pins
• E302BDIP20009: Applicator with K-Wire Ø2.0 mm, disposable, for 2.0 mm pins
• E302BDIP15009: Applicator with K-wire Ø1.6 mm, disposable, for 1.5 mm pins