← Back to catalogue

Cemex System Container

FDA UDI

Class I (US FDA UDI)

by Tecres

Identity

Trade Name
Cemex System Container FDA UDI
Generic Name
Orthopaedic cement mixing container, single-use FDA UDI
Device Name
Cemex System Container is a container for Tecres' Cemex System that allows the mixing of Cemex System bone cement into Tecres' Cemex System Mixer. FDA UDI
Model / Reference
ASA0030 FDA UDI
Description
Cemex System Container is a container for Tecres' Cemex System that allows the mixing of Cemex System bone cement into Tecres' Cemex System Mixer. FDA UDI

Identifiers

Primary DI / UDI-DI
08031497002675 FDA UDI
FDA Product Code
JDZ FDA UDI
GMDN Term
Orthopaedic cement mixing container, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic cement mixing container, single-use

Cemex System Container by Tecres — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic cement mixing container, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Tecres

Sources (1)

  • FDA UDI bf367efb-239f-4e03-a2eb-891854f7e98c 33 fields · synced May 30, 2026