Identity
- Trade Name
- Smartscraper EUDAMEDFDA UDI
- Generic Name
- Bone collection scraper FDA UDI
- Device Name
- SAFESCRAPER TWIST EUDAMEDSMARTSCRAPER is a medical device intended for harvesting, collecting and direct release, thanks to an integrated syringe, of autologous bone in regenerative applications in oral surgery. FDA UDI
- Model / Reference
- 4890 EUDAMEDFDA UDI3598 EUDAMED
- Description
- SMARTSCRAPER is a medical device intended for harvesting, collecting and direct release, thanks to an integrated syringe, of autologous bone in regenerative applications in oral surgery. FDA UDI
Identifiers
- Catalog Number
- 4890 FDA UDI
- Primary DI / UDI-DI
- 08056585230037 EUDAMEDFDA UDI
- Basic UDI-DI
- 805658523SCRAPEMA EUDAMED
- FDA Product Code
- MXP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Bone collection scraper FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.4800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone collection scraper
Smartscraper by Meta Technologies Srl — 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
- Meta Technologies Srl
Sources (2)
- FDA UDI 291b2a6b-7532-4add-88ef-d99dcb386c52 34 fields · synced Jul 9, 2026
- EUDAMED c95f7cde-5878-44dd-8dfb-cc7fb5230531 61 fields · synced Jul 9, 2026