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b-ONE™ Primary Acetabular System

FDA UDI

Class II (US FDA UDI)

by b-ONE Ortho Corp.

Identity

Trade Name
b-ONE™ Primary Acetabular System FDA UDI
Generic Name
Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
Device Name
SHELL TRIAL, 54MM OUTER DIAMETER, LINER SIZE H FDA UDI
Model / Reference
881906154H FDA UDI
Description
SHELL TRIAL, 54MM OUTER DIAMETER, LINER SIZE H FDA UDI

Identifiers

Catalog Number
881906154H FDA UDI
Primary DI / UDI-DI
00843575100184 FDA UDI
FDA Product Code
HWC FDA UDI
MEH FDA UDI
LZO FDA UDI
GMDN Term
Acetabulum prosthesis trial, prefabricated, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3353 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Acetabulum prosthesis trial, prefabricated, reusable

b-ONE™ Primary Acetabular System by b-ONE Ortho Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Acetabulum prosthesis trial, prefabricated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
b-ONE Ortho Corp.

Sources (1)

  • FDA UDI 2002a103-df9d-4867-824e-c7ec857c0c14 34 fields · synced May 30, 2026