RALLY All In One Cement Gun

FDA UDI

Class I (US FDA UDI)

by Tecres

Identity

Trade Name: RALLY All In One Cement Gun FDA UDI
Generic Name: Orthopaedic cement/bone filler dispensing gun FDA UDI
Device Name: RALLY ALL IN ONE CEMENT GUN is intended to be used for helping the extrusion (and hence the delivery) of the bone cement prepared with the RALLY ALL IN ONE SYSTEM devices. FDA UDI
Model / Reference: 71271610 FDA UDI
Description: RALLY ALL IN ONE CEMENT GUN is intended to be used for helping the extrusion (and hence the delivery) of the bone cement prepared with the RALLY ALL IN ONE SYSTEM devices. FDA UDI

Identifiers

Primary DI / UDI-DI: 08031497002330 FDA UDI
FDA Product Code: KIH FDA UDI
GMDN Term: Orthopaedic cement/bone filler dispensing gun FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic cement/bone filler dispensing gun

RALLY All In One Cement Gun by Tecres — 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: Tecres

Sources (1)

FDA UDI 33be2c13-832b-41fd-b023-e402a1990287 33 fields · synced May 30, 2026