Blade - Straight XL (8mm)

FDA UDI

Class I (US FDA UDI)

by Mc Bio Srl

Identity

Trade Name: Blade - Straight XL (8mm) FDA UDI
Generic Name: Bone file/rasp, manual, reusable FDA UDI
Device Name: Blade - Straight XL (8mm) Replace blade XL for Straight XL bone scraper of MCBio FDA UDI
Model / Reference: 39770 FDA UDI
Description: Blade - Straight XL (8mm) Replace blade XL for Straight XL bone scraper of MCBio FDA UDI

Identifiers

Primary DI / UDI-DI: 08057639712288 FDA UDI
FDA Product Code: EMK FDA UDI
GMDN Term: Bone file/rasp, manual, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone file/rasp, manual, reusable

Blade - Straight XL (8mm) by Mc Bio Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone file/rasp, manual, reusable.

Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
Life Instruments — Life Instrument Corporation · Class I
TALOS®-C — MEDITECH SPINE, LLC · Class II
DeGen Standard Instrumentation — Degen Medical · Class I
TiWave C Cervical Cage System — Kalitec Direct LLC · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
4WEB Medical — 4Web Medical, Inc. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Mc Bio Srl

Sources (1)

FDA UDI 0409d447-c506-40d6-be4d-e8d741c238ae 33 fields · synced May 30, 2026