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Pit'stop
EUDAMEDFDA UDIClass I (EU MDR)
Ref M02 10021Model A06 10011
by In2Bones SAS
Identity
- Trade Name
- PIT'STOP EUDAMEDPIT'STOP® FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- PIT'STOP CONTAINER BASE REUSABLE INSTRUMENTS FDA UDI
- Model / Reference
- A06 10011 EUDAMEDM02 10021 EUDAMEDFDA UDI
- Description
- PIT'STOP CONTAINER BASE REUSABLE INSTRUMENTS FDA UDI
Identifiers
- Catalog Number
- M02 10021 FDA UDI
- Primary DI / UDI-DI
- 03760225713327 EUDAMEDFDA UDI
- Basic UDI-DI
- 3701337640927F EUDAMED
- Direct Marketing DI
- 03760225713327 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
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
Pit'stop by In2Bones SAS — 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 | 3701337640927F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (3)
- EUDAMED 5bdf1a4e-abe5-4530-b25b-d27b4722be43 61 fields · synced Jul 15, 2026
- FDA UDI 24c031cb-0831-4805-953a-a19c1476ec69 35 fields · synced May 30, 2026
- EUDAMED 38092c6a-7b10-494e-8f5d-4ae464d95830 61 fields · synced Jul 15, 2026