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HMAX Dual Offset Broach Handle - Right

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 9095.11.002

by Enztec Limited

Identity

Trade Name
HMAX Dual Offset Broach Handle - Right EUDAMED
HMAX Dual Offset Broach Handle Right FDA UDI
Generic Name
Surgical instrument handle, non-torque-limiting FDA UDI
Device Name
Broach Handles EUDAMED
A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Model / Reference
9095.11.002 EUDAMEDFDA UDI
Description
A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI

Identifiers

Catalog Number
9095.11.002 FDA UDI
Primary DI / UDI-DI
09421028111669 EUDAMEDFDA UDI
Basic UDI-DI
942102811GMN0002ZS EUDAMED
Direct Marketing DI
09421028111669 EUDAMED
FDA Product Code
LXH FDA UDI
EMDN Code
L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
GMDN Term
Surgical instrument handle, non-torque-limiting FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
888.4540 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

HMAX Dual Offset Broach Handle - Right by Enztec Limited — Class I — 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
Enztec Limited
EUDAMED SRN
NZ-MF-000002264
Authorised Representative
Advena Limited MT-AR-000000234

Sources (2)

  • EUDAMED d47acf69-6db7-4f28-8995-9e2e0e34abf3 61 fields · synced Jul 10, 2026
  • FDA UDI c61f3528-3739-42e0-a033-3a9f5a0e8ca4 34 fields · synced May 30, 2026