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Purekit Gun Mv

EUDAMEDFDA UDI

Class III (EU MDR)

Ref T060425MV

by Teknimed Sas

Identity

Trade Name
PUREKIT GUN MV EUDAMEDFDA UDI
Generic Name
Orthopaedic cement preparation/delivery kit FDA UDI
Device Name
PUREKIT MV EUDAMED
Model / Reference
T060425MV EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
03760177045361 EUDAMEDFDA UDI
Basic UDI-DI
376017704B34D9 EUDAMED
FDA Product Code
NDN FDA UDI
OAR FDA UDI
JDZ FDA UDI
EMDN Code
P099002 ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS EUDAMED
GMDN Term
Orthopaedic cement preparation/delivery kit FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
888.3027 FDA UDI
888.4200 FDA UDI
888.4210 FDA UDI
Medical Purpose
The system is intended to mix and inject medium viscosity bone cement during cementoplasty procedures. EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Purekit Gun Mv by Teknimed Sas — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teknimed Sas
EUDAMED SRN
FR-PR-000001226

Sources (2)

  • EUDAMED c80bedb2-0283-4804-bca6-beee6eb24db1 61 fields · synced Jul 9, 2026
  • FDA UDI 70775e5a-582d-4ba5-a8cb-c4e4094c577a 32 fields · synced May 30, 2026