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Kinematic Alignment Caliper - S+N
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4240-7354Ref 4240-7349
Identity
- Trade Name
- Kinematic Alignment Caliper - S+N EUDAMEDKinematic Alignment Caliper EUDAMEDFDA UDIKinematic Alignment Caliper – S+N FDA UDI
- Generic Name
- Medical ruler, reusable FDA UDI
- Device Name
- Calipers EUDAMEDA reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDIIntended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces FDA UDI
- Model / Reference
- 4240-7354 EUDAMEDFDA UDI4240-7349 EUDAMEDFDA UDI
- Description
- A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDIIntended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces FDA UDI
Identifiers
- Catalog Number
- 4240-7354 FDA UDI4240-7349 FDA UDI
- Primary DI / UDI-DI
- 09421028119290 EUDAMEDFDA UDI09421028112963 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN0003ZU EUDAMED
- Direct Marketing DI
- 09421028119290 EUDAMED09421028112963 EUDAMED
- FDA Product Code
- KTZ FDA UDI
- EMDN Code
- L0923 ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE EUDAMED
- GMDN Term
- Medical ruler, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4150 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Kinematic Alignment Caliper - S+N 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 942102811GMN0003ZU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (4)
- EUDAMED f1c53db6-d678-4059-8611-3d600ed6bab7 61 fields · synced Jul 10, 2026
- FDA UDI 3be44c62-1eb2-48af-9cc2-103a0f240dbc 34 fields · synced May 29, 2026
- FDA UDI 999bd07a-1f5e-4195-af80-2044570c26fa 34 fields · synced May 30, 2026
- EUDAMED c74427ca-8909-47f6-80ca-ac92902a6448 61 fields · synced Jul 10, 2026