Djo Surgical

FDA UDI

Class I (US FDA UDI)

by Encore Medical, L.p.

Identity

Trade Name: DJO SURGICAL FDA UDI
Generic Name: Orthopaedic cement, non-antimicrobial FDA UDI
Device Name: OPTIVAC TOTAL HIP KIT 40GM AND 80GM FDA UDI
Model / Reference: 600-50-004 FDA UDI
Description: OPTIVAC TOTAL HIP KIT 40GM AND 80GM FDA UDI

Identifiers

Primary DI / UDI-DI: 00190446138037 FDA UDI
FDA Product Code: LXH FDA UDI
JDZ FDA UDI
GMDN Term: Orthopaedic cement, non-antimicrobial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
888.4210 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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, non-antimicrobial

Djo Surgical by Encore Medical, L.p. — 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: Encore Medical, L.p.

Sources (1)

FDA UDI 36b92b78-5941-4a6a-bbcb-07d0613ca77f 33 fields · synced May 30, 2026