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Jota
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 806104249523014Model Rotary Instruments
by Jota AG
Identity
- Trade Name
- JOTA FDA UDI
- Generic Name
- Podiatric bur, reusable FDA UDI
- Device Name
- Diamond Podology FDA UDI
- Model / Reference
- Rotary Instruments EUDAMED806104249523014 EUDAMEDP862.HP.014 FDA UDI
- Description
- Diamond Podology FDA UDI
Identifiers
- Primary DI / UDI-DI
- EJOT806104249523014 EUDAMEDFDA UDI
- Basic UDI-DI
- B-EJOT806104249523014 EUDAMED
- FDA Product Code
- DZP FDA UDI
- EMDN Code
- L0916 ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE EUDAMED
- GMDN Term
- Podiatric bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4535 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Podiatric bur, reusable
Jota by Jota AG — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jota AG
Sources (2)
- FDA UDI e8ada912-94a5-4f1a-8cfd-f19fbad8f5b5 33 fields · synced Jul 8, 2026
- EUDAMED 8da26a0e-c693-442b-aac5-667c54ad67ab 61 fields · synced Jul 8, 2026