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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
Cannulated surgical drill bit, single-use, non-sterile FDA UDI
Device Name
SHIP Long/Shaw Drill Regular FDA UDI
Model / Reference
90-301-23-S FDA UDI
Description
SHIP Long/Shaw Drill Regular FDA UDI

Identifiers

Catalog Number
90-301-23-S FDA UDI
Primary DI / UDI-DI
00819034029235 FDA UDI
FDA Product Code
KWH FDA UDI
GMDN Term
Cannulated surgical drill bit, single-use, non-sterile 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

Yes

FDA UDI

Single Use

Yes

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

Category: Cannulated surgical drill bit, single-use, non-sterile

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

Similar devices

Also classified as Cannulated surgical drill bit, single-use, non-sterile.

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 974b0e4c-9b21-41d0-b86b-c03f5e6247f4 34 fields · synced May 31, 2026