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Disposable Pin Applicator

FDA UDI

Class II (US FDA UDI)

by Bioretec Oy

Identity

Trade Name
Disposable Pin Applicator FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Applicator with K-Wire Ø2.8 mm, disposable, for 2.7 mm pins FDA UDI
Model / Reference
B-DIP-2700 FDA UDI
Description
Applicator with K-Wire Ø2.8 mm, disposable, for 2.7 mm pins FDA UDI

Identifiers

Catalog Number
B-DIP-2700 FDA UDI
Primary DI / UDI-DI
E302BDIP27009 FDA UDI
510(k) Number
K080879 FDA UDI
FDA Product Code
HTY FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 2.7 Millimeter FDA UDI

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

Disposable Pin Applicator by Bioretec Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

Cleared under the same submission

K080879 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioretec Oy

Sources (1)

  • FDA UDI 36f126c8-586d-4d70-840d-94783e634eef 37 fields · synced May 31, 2026