Smartseal

FDA UDI

Class I (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: SMARTSEAL FDA UDI
Generic Name: Orthopaedic cement compressor FDA UDI
Device Name: SmartSeal Wedge Femoral Pressuriser FDA UDI
Model / Reference: 3206-002 FDA UDI
Description: SmartSeal Wedge Femoral Pressuriser FDA UDI

Identifiers

Catalog Number: 3206002 FDA UDI
Primary DI / UDI-DI: 10603295168393 FDA UDI
FDA Product Code: KIH FDA UDI
GMDN Term: Orthopaedic cement compressor FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4200 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

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

Category: Orthopaedic cement compressor

Smartseal by Depuy (ireland) — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Depuy (ireland)

Sources (1)

FDA UDI 6eb6090b-a4b4-4cd6-90dd-cf374aa78e15 36 fields · synced Jun 8, 2026