Capture™

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: CAPTURE™ FDA UDI
Generic Name: Intramedullary canal cleaning brush, reusable FDA UDI
Device Name: CAPTURE™ High Torque Screw System The cannula cleaning stylet is used to clean all cannulated instruments. This instrument is used with 4.0 and 5.0 mm instruments. FDA UDI
Model / Reference: AI-3205 FDA UDI
Description: CAPTURE™ High Torque Screw System The cannula cleaning stylet is used to clean all cannulated instruments. This instrument is used with 4.0 and 5.0 mm instruments. FDA UDI

Identifiers

Catalog Number: AI3205 FDA UDI
Primary DI / UDI-DI: 10381780241942 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Intramedullary canal cleaning brush, 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: Intramedullary canal cleaning brush, reusable

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

Similar devices

Also classified as Intramedullary canal cleaning brush, reusable.

FEMORAL CANAL BRUSH — Biomet Orthopedics, Inc. · Class I
Cleaning Brush φ1.0 — Double Medical Technology Inc. · Class II
Capture High Torque Screw System — Smith & Nephew, Inc. · Class I
Capture High Torque Screw System — Smith & Nephew, Inc. · Class I
Capture High Torque Screw System — Smith & Nephew, Inc. · Class I
Cleaning Brush — Double Medical Technology Inc. · Class II
CAPTURE™ — Ascension Orthopedics, Inc. · Class I
CAPTURE™ — Ascension Orthopedics, Inc. · 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 04bf3eba-a8c2-4180-8353-d7155445ed56 36 fields · synced May 30, 2026