Identity
- Trade Name
- LOQTEQ® FDA UDI
- Generic Name
- Orthopaedic implant aiming/guiding block attachment tool FDA UDI
- Device Name
- Marking plug for handle of targeting frame LOQTEQ DF 4.5 FDA UDI
- Model / Reference
- IU 8175-08 EUDAMEDFDA UDIInstrument EUDAMED
- Description
- Marking plug for handle of targeting frame LOQTEQ DF 4.5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04042409220104 EUDAMEDFDA UDI
- Basic UDI-DI
- 40424090111GP EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic implant aiming/guiding block attachment tool FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany 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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant aiming/guiding block attachment tool
Loqteq® by aap Implantate AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- aap Implantate AG
Sources (2)
- FDA UDI 2c7950c5-f4cd-4c01-ae67-16f40ce6df09 33 fields · synced Jul 23, 2026
- EUDAMED b33db8fa-a6c1-4d62-ad60-bc7dff61bd74 61 fields · synced Jul 23, 2026