Sa-002

FDA UDI

Class I (US FDA UDI)

by GNI Co., Ltd

Identity

Trade Name: SA-002 FDA UDI
Generic Name: Surgical screwdriver, reusable FDA UDI
Model / Reference: SA-002 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800046045810 FDA UDI
FDA Product Code: ECT FDA UDI
GMDN Term: Surgical screwdriver, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical screwdriver, reusable

Sa-002 by GNI Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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USS — Synthes · Class I
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I

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: GNI Co., Ltd

Sources (1)

FDA UDI f1ba0106-e079-488d-8b8b-8d1e03a41c8e 32 fields · synced Jun 6, 2026