2Mix Gun

FDA UDI

Class I (US FDA UDI)

by Tecres

Identity

Trade Name: 2Mix Gun FDA UDI
Generic Name: Orthopaedic cement/bone filler dispensing gun FDA UDI
Device Name: 2Mix Gun is designed to aid the extrusion of bone cement from 2Mix. FDA UDI
Model / Reference: ASA0310 FDA UDI
Description: 2Mix Gun is designed to aid the extrusion of bone cement from 2Mix. FDA UDI

Identifiers

Primary DI / UDI-DI: 08031497002057 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

Yes

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

2Mix Gun by Tecres — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Prism II Ratchet Delivery Gun — Summit Medical, LLC · Class I
Bone Cement Delivery Gun — Summit Medical, LLC · Class I

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 3500c1d1-6d1b-434f-8e0c-3f147f52984a 33 fields · synced Jun 8, 2026