Capture™

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: CAPTURE™ FDA UDI
Generic Name: Orthopaedic guidewire, reusable FDA UDI
Device Name: CAPTURE™ High Torque Screw System The guide wire is used as a guide for placement or insertion of a device. The plain guide wires have a trocar tip. FDA UDI
Model / Reference: AW-3002 FDA UDI
Description: CAPTURE™ High Torque Screw System The guide wire is used as a guide for placement or insertion of a device. The plain guide wires have a trocar tip. FDA UDI

Identifiers

Catalog Number: AW3002 FDA UDI
Primary DI / UDI-DI: 10381780242116 FDA UDI
FDA Product Code: HXI FDA UDI
GMDN Term: Orthopaedic guidewire, reusable 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic guidewire, reusable

Capture™ by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic guidewire, reusable.

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Guide Wire — I.T.S. GmbH · Class I
Parallel Wire Guide, for φ2.5 Guide Wire, Adjustable — Double Medical Technology Inc. · Class II
VERTECEM — Synthes GmbH · Class IIa
Adapter Fibre Optic Cable Light Cable — Synthes GmbH · Class I
ZERO-P — Synthes GmbH · Class IIa
Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · 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: Ascension Orthopedics, Inc.

Sources (1)

FDA UDI f42c765e-49fb-4b7c-b59c-a3b1b9b3bfaa 37 fields · synced May 30, 2026