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Reduction Screw Caddy 8.5mm/9.0mm Screws

FDA UDI

Class I (US FDA UDI)

by Captiva Spine

Identity

Trade Name
Reduction Screw Caddy 8.5mm/9.0mm Screws FDA UDI
Generic Name
General external orthopaedic fixation system implantation kit, reusable FDA UDI
Model / Reference
16401-1905 FDA UDI

Identifiers

Primary DI / UDI-DI
M739164011905 FDA UDI
FDA Product Code
FSM FDA UDI
GMDN Term
General external orthopaedic fixation system implantation kit, 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

No

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: General external orthopaedic fixation system implantation kit, reusable

Reduction Screw Caddy 8.5mm/9.0mm Screws by Captiva Spine — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General external orthopaedic fixation system implantation kit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Captiva Spine

Sources (1)

  • FDA UDI 3d2751ec-ef57-4640-bcce-24ad8e6ed839 33 fields · synced Jun 8, 2026