Prophecy

FDA UDI

Class II (US FDA UDI)

by MicroPort Orthopedics Inc.

Identity

Trade Name: PROPHECY FDA UDI
Generic Name: Joint prosthesis implantation kit, reusable FDA UDI
Model / Reference: PNV04231 FDA UDI

Identifiers

Catalog Number: PNV04231 FDA UDI
Primary DI / UDI-DI: M684PNV042311 FDA UDI
FDA Product Code: OOG FDA UDI
MBH FDA UDI
JWH FDA UDI
GMDN Term: Joint prosthesis implantation kit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Joint prosthesis implantation kit, reusable

Prophecy by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Joint prosthesis implantation kit, reusable.

Initia Total Hip System — Kyocera Corporation · Class II
Cadence Total Ankle System — Smith & Nephew, Inc. · Class I
G7 MINI TRAY — Biomet Orthopedics, Inc. · Class II
APEX Knee System — OMNIlife science, Inc. · Class I
Initia Total Hip System — Kyocera Corporation · Class I
APEX Knee System — OMNIlife science, Inc. · Class I
Engage Partial Knee System — Engage Uni, LLC · Class II
DFS — Biomet Orthopedics, Inc. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: MicroPort Orthopedics Inc.

Sources (1)

FDA UDI f97e4a52-6cd7-4af4-bf30-3d2480c4e88a 34 fields · synced Jun 9, 2026