Capture™

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: CAPTURE™ FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: CAPTURE™ High Torque Screw System The Capture 7.0mm Instrument Drop Plate is a separate tray within the base where devices are held. FDA UDI
Model / Reference: CSA-5000-006 FDA UDI
Description: CAPTURE™ High Torque Screw System The Capture 7.0mm Instrument Drop Plate is a separate tray within the base where devices are held. FDA UDI

Identifiers

Catalog Number: CSA5000006 FDA UDI
Primary DI / UDI-DI: 10381780243687 FDA UDI
FDA Product Code: OJH 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

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: Instrument tray, reusable

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

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Instrument Case — Katena Products, Inc. · Class I
Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
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ASELTECH — Asel Tibbi Aletler A.S. · 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 695ee0dd-8d5d-4ee0-96bf-5959fd2017db 37 fields · synced May 31, 2026