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Optima™ Spinal System

FDA UDI

Class I (US FDA UDI)

by CG MedTech Co., Ltd.

Identity

Trade Name
Optima™ Spinal System FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Model / Reference
SP001-C FDA UDI

Identifiers

Primary DI / UDI-DI
08800015952392 FDA UDI
FDA Product Code
FSM FDA UDI
GMDN Term
Instrument tray, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Instrument tray, reusable

The Optima Spinal System is a reusable instrument tray designed for general plastic surgery, offering a convenient and sterile platform for placing instruments during procedures. This device features a moulded position system, allowing for easy placement of medical devices, and includes a removable identification tag for accurate tracking.

Similar devices

Also classified as Instrument tray, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CG MedTech Co., Ltd.

Sources (1)

  • FDA UDI e42d6535-bf37-4a44-84bf-5cd8f3c58be4 33 fields · synced Jul 30, 2026