MIS Instrument Tray Assembly

FDA UDI

Class I (US FDA UDI)

by Captiva Spine

Identity

Trade Name: MIS Instrument Tray Assembly FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Model / Reference: 16331-0801 FDA UDI

Identifiers

Primary DI / UDI-DI: M739163310801 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Instrument tray, reusable

MIS Instrument Tray Assembly by Captiva Spine — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Captiva Spine

Sources (1)

FDA UDI 1a7028b4-f616-4871-912e-a376d92d6a86 33 fields · synced Jun 1, 2026