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Djo Surgical

FDA UDI

Class I (US FDA UDI)

by Djo, Llc

Identity

Trade Name
DJO SURGICAL FDA UDI
Generic Name
Orthopaedic femur reamer trial FDA UDI
Device Name
REAMER,SPIRAL FEMUR 16.5MM FDA UDI
Model / Reference
803-00-091 FDA UDI
Description
REAMER,SPIRAL FEMUR 16.5MM FDA UDI

Identifiers

Primary DI / UDI-DI
00888912089005 FDA UDI
FDA Product Code
HTO FDA UDI
GMDN Term
Orthopaedic femur reamer trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic femur reamer trial

Djo Surgical by Djo, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic femur reamer trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Djo, Llc

Sources (1)

  • FDA UDI 93c09ac9-ca00-4044-9525-80a8ac1d70cf 33 fields · synced May 31, 2026