Disposable Pin Applicator

Basic Information

• Brand Name: Disposable Pin Applicator
• Primary DI: 06438394002333
• Version / Model: B-DIP-2700
• Catalog Number: B-DIP-2700
• Company Name: Bioretec Oy
• Labeler DUNS: 368715301
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-03
• Public Version: 1
• Public Version Date: 2026-02-11
• Public Version Status: New
• Public Device Record Key: 3bf086bf-8572-4fec-8606-f059a63664ae

Device Description

Applicator with K-Wire Ø2.8 mm, disposable, for 2.7 mm pins

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTY	Pin, Fixation, Smooth	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44052	Orthopaedic surgical procedure kit, non-medicated, single-use	A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06438394002333	GS1
Previous	E302BDIP27009	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K080879	000

Device Sizes

Type	Value	Unit	Text
Width	2.7	Millimeter