Guia De Fresa Ø3.mm

FDA UDI

Class I (US FDA UDI)

by S.I.N. - Sistema DE Implante Nacional S.A.

Identity

Trade Name: GUIA DE FRESA Ø3.MM FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: GUIA DE FRESA Ø3.MM FDA UDI
Model / Reference: HGF 30 FDA UDI
Description: GUIA DE FRESA Ø3.MM FDA UDI

Identifiers

Primary DI / UDI-DI: 07899995209023 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Surgical drill guide, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, reusable

Guia De Fresa Ø3.mm by S.I.N. - Sistema DE Implante Nacional S.A. — 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: S.I.N. - Sistema DE Implante Nacional S.A.

Sources (1)

FDA UDI e0d3241f-b34c-43e4-9996-08650131f7d1 33 fields · synced Jun 8, 2026