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Safescraper Twist Curve Volumizer
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 5535Model 3598
Identity
- Trade Name
- Safescraper Twist Curve Volumizer EUDAMEDFDA UDI
- Generic Name
- Bone collection scraper FDA UDI
- Device Name
- SAFESCRAPER TWIST EUDAMEDSAFESCRAPER TWIST Curve VOLUMIZER is a medical device intended to harvest, collect, and release autologous bone in regenerative applications in oral surgery. FDA UDI
- Model / Reference
- 5535 EUDAMEDFDA UDI3598 EUDAMED
- Description
- SAFESCRAPER TWIST Curve VOLUMIZER is a medical device intended to harvest, collect, and release autologous bone in regenerative applications in oral surgery. FDA UDI
Identifiers
- Catalog Number
- 5535 FDA UDI
- Primary DI / UDI-DI
- 08056585230198 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
Dimensions & Sizes
- Size
- Length — 155.7 Millimeter FDA UDIHeight — 15.6 Millimeter FDA UDIWidth — 15.2 Millimeter FDA UDI
Category: Bone collection scraper
Safescraper Twist Curve Volumizer by Meta Technologies Srl — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Bone collection scraper.
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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 a80ebe9b-a373-4684-9bbf-42f02727cf8d 36 fields · synced Jul 10, 2026
- EUDAMED 88ff4609-8625-4175-8904-09554eec0d7b 61 fields · synced Jul 10, 2026