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Sgarlato Silastic

FDA UDI

Class II (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name
Sgarlato Silastic FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
GAIT Pick and Press Inserter FDA UDI
Model / Reference
30-300-02 FDA UDI
Description
GAIT Pick and Press Inserter FDA UDI

Identifiers

Catalog Number
30-300-02 FDA UDI
Primary DI / UDI-DI
00819034028856 FDA UDI
FDA Product Code
KWH FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Sgarlato Silastic by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fusion Orthopedics, Llc

Sources (1)

  • FDA UDI 79b343a5-0c5f-4eb3-b76e-91998bf8d403 34 fields · synced May 30, 2026