Sgarlato Silastic

FDA UDI

Class II (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name: Sgarlato Silastic FDA UDI
Generic Name: Bone-resection orthopaedic reamer, single-use FDA UDI
Device Name: GAIT Broach (Diamond) Proximal FDA UDI
Model / Reference: 30-301-52 FDA UDI
Description: GAIT Broach (Diamond) Proximal FDA UDI

Identifiers

Catalog Number: 30-301-52 FDA UDI
Primary DI / UDI-DI: 00819034028832 FDA UDI
FDA Product Code: KWH FDA UDI
GMDN Term: Bone-resection orthopaedic reamer, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3720 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone-resection orthopaedic reamer, single-use

Sgarlato Silastic by Fusion Orthopedics, Llc — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Fusion Orthopedics, Llc

Sources (1)

FDA UDI cdc34144-f3f8-443d-9d68-674bc71811c2 34 fields · synced May 31, 2026