Blustone Synergy Cervical Rasp

FDA UDI

Class I (US FDA UDI)

by Blustone Synergy

Identity

Trade Name: Blustone Synergy Cervical Rasp FDA UDI
Generic Name: Bone file FDA UDI
Device Name: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical rasps are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm. FDA UDI
Model / Reference: 9017-CRL6 FDA UDI
Description: The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical rasps are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810482031139 FDA UDI
FDA Product Code: HTR FDA UDI
GMDN Term: Bone file FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

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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

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 13 Millimeter FDA UDI
Height — 6 Millimeter FDA UDI
Length — 17 Millimeter FDA UDI

Category: Bone file

Blustone Synergy Cervical Rasp by Blustone Synergy — 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: Blustone Synergy

Sources (1)

FDA UDI 1117c356-4f53-4789-82da-58edaf656619 35 fields · synced Jun 8, 2026