Acetabular Shell

FDA UDI

Class II (US FDA UDI)

by Shalby Advanced Technologies, Inc.

Identity

Trade Name: Acetabular Shell FDA UDI
Generic Name: Acetabular shell FDA UDI
Device Name: CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 46mm FDA UDI
Model / Reference: 1701-0-0046 FDA UDI
Description: CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 46mm FDA UDI

Identifiers

Catalog Number: 1701-0-0046 FDA UDI
Primary DI / UDI-DI: 00840286800020 FDA UDI
FDA Product Code: LPH FDA UDI
GMDN Term: Acetabular shell FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 46 Millimeter FDA UDI

Category: Acetabular shell

Acetabular Shell by Shalby Advanced Technologies, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Shalby Advanced Technologies, Inc.

Sources (1)

FDA UDI 68b7ea66-e9a6-4ce3-a87e-3ea184a74210 36 fields · synced May 30, 2026