Osteotec Silicone Finger - Proximal Rasp Size 3

FDA UDI

Class I (US FDA UDI)

by Osteotec, Ltd.

Identity

Trade Name: Osteotec Silicone Finger - Proximal Rasp Size 3 FDA UDI
Generic Name: Bone file/rasp, manual, reusable FDA UDI
Device Name: The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem. FDA UDI
Model / Reference: OSTF-3P FDA UDI
Description: The 11 distal (blue handle) and 11 proximal (whithe handle) rasps are device specific instruments used to create bone cavities for the implantation of the Osteotec Silicone Finger Implant. Each rasp is dedicated to a particular size of implant and is based on the design of the proximal or distal stem. FDA UDI

Identifiers

Catalog Number: OSTF-3P FDA UDI
Primary DI / UDI-DI: 05060183094673 FDA UDI
FDA Product Code: HTQ FDA UDI
GMDN Term: Bone file/rasp, manual, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

Yes

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone file/rasp, manual, reusable

Osteotec Silicone Finger - Proximal Rasp Size 3 by Osteotec, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Osteotec, Ltd.

Sources (1)

FDA UDI 02cbca87-3369-406e-89bb-714ce4f5806a 34 fields · synced Jun 8, 2026