Sierra

FDA UDI

Class I (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name: Sierra FDA UDI
Generic Name: Orthopaedic implant driver FDA UDI
Device Name: Variable Angle 4mm Hex Driver FDA UDI
Model / Reference: 95-0264 FDA UDI
Description: Variable Angle 4mm Hex Driver FDA UDI

Identifiers

Catalog Number: 95-0264 FDA UDI
Primary DI / UDI-DI: 10889981095550 FDA UDI
FDA Product Code: HXX FDA UDI
GMDN Term: Orthopaedic implant driver FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implant driver

Sierra by SeaSpine Orthopedics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Hex Driver — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
T8 Driver 200mm AO QC — Zimmer, Inc. · Class I
CoLink — In2Bones, USA · Class I
Graft Delivery System — Nuvasive, Inc. · Class I
Excella III-D® — Innovasis, Inc. · Class II

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: SeaSpine Orthopedics Corporation

Sources (1)

FDA UDI 83dae0d2-5dae-4aeb-a5a0-0cac68d2d1ea 36 fields · synced Jun 8, 2026