Disposable Pin Applicator B-DIP-1500

GUDID 06438394002319

Applicator with K-wire Ø1.6 mm, disposable, for 1.5 mm pins

Bioretec Oy

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

• Primary Device ID: 06438394002319
• NIH Device Record Key: 4a8fd8db-6604-4113-8e49-561557ef5fe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Pin Applicator
• Version Model Number: B-DIP-1500
• Catalog Number: B-DIP-1500
• 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
• Phone: +358207789500
• Email: sales@bioretec.com
• Phone: +358207789500
• Email: sales@bioretec.com

Device Dimensions

• Width: 1.5 Millimeter
• Width: 1.5 Millimeter
• Width: 1.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06438394002319 [Primary]
HIBCC	E302BDIP15009 [Previous]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-13
• Device Publish Date: 2026-02-05

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
• 06438394002333: Applicator with K-Wire Ø2.8 mm, disposable, for 2.7 mm pins
• 06438394002326: Applicator with K-Wire Ø2.0 mm, disposable, for 2.0 mm pins
• 06438394002319: Applicator with K-wire Ø1.6 mm, disposable, for 1.5 mm pins