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Reflection

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
REFLECTION FDA UDI
Generic Name
Acetabular shell FDA UDI
Device Name
REFLECTION FINNED SP3 THREE HOLE SHELL SIZE 54MM FDA UDI
Model / Reference
71932022 FDA UDI
Description
REFLECTION FINNED SP3 THREE HOLE SHELL SIZE 54MM FDA UDI

Identifiers

Catalog Number
71932022 FDA UDI
Primary DI / UDI-DI
03596010571915 FDA UDI
510(k) Number
K960094 FDA UDI
FDA Product Code
MBL FDA UDI
GMDN Term
Acetabular shell FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3358 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Reflection by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K960094 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 38240994-2259-43ce-a68d-652da35ece02 37 fields · synced Jun 8, 2026