TRAcelet™

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: TRAcelet™ FDA UDI
Generic Name: Radial artery compression device FDA UDI
Device Name: COMPRESSION DEVICE TRACL TRACELET 5PK GL FDA UDI
Model / Reference: TRACL FDA UDI
Description: COMPRESSION DEVICE TRACL TRACELET 5PK GL FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169900899 FDA UDI
510(k) Number: K162027 FDA UDI
FDA Product Code: DXC FDA UDI
GMDN Term: Radial artery compression device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 25.2 Centimeter FDA UDI

Category: Radial artery compression device

TRAcelet™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radial artery compression device.

PreludeSYNC™ — Merit Medical Systems, Inc. · Class II
PreludeSYNC DISTAL™ — Merit Medical Systems, Inc. · Class II
Cordis Zephyr Vascular Compression Band — Semler Technologies, Inc. · Class II
MEDADV — MEDAS, INC. · Class II
HemCon® ChitoPulse™, 15 inch — Tricol Biomedical, INC. · Class II
PreludeSYNC™ — Merit Medical Systems, Inc. · Class II
PreludeSYNC DISTAL™ — Merit Medical Systems, Inc. · Class II
PreludeSYNC EVO™ — Merit Medical Systems, Inc. · Class II

Cleared under the same submission

K162027 also covers:

TRAcelet™ — MEDTRONIC, INC.

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 II	Pending data

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Manufacturer

Manufacturer: Medtronic, Inc.

Sources (1)

FDA UDI ca0d12ba-3406-4507-ad64-ae84be44c388 37 fields · synced May 30, 2026