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Elite
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref EL-3020S4Model BME ELITE, BME ELITE Y, BME SPEED, SPEEDTITAN, SPEEDARC, SPEEDTRIAD, SPEEDSHIFT Implant Kits
by Synthes
Identity
- Trade Name
- BME ELITE EUDAMEDElite FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Device Name
- BME ELITE, BME ELITE Y, BME SPEED, SPEEDTITAN, SPEEDARC, SPEEDTRIAD, SPEEDSHIFT Implant Kits EUDAMEDELITE 30x20x20mm, Straight Bridge, 4 Legs FDA UDI
- Model / Reference
- EL-3020S4 EUDAMEDFDA UDIBME ELITE, BME ELITE Y, BME SPEED, SPEEDTITAN, SPEEDARC, SPEEDTRIAD, SPEEDSHIFT Implant Kits EUDAMED
- Description
- ELITE 30x20x20mm, Straight Bridge, 4 Legs FDA UDI
Identifiers
- Catalog Number
- EL3020S4 FDA UDI
- Primary DI / UDI-DI
- 00810633021712 EUDAMEDFDA UDI
- Basic UDI-DI
- 7611819a00645K4 EUDAMED
- FDA Product Code
- JDR FDA UDI
- EMDN Code
- P09120101 OSTEOSYNTHESIS STAPLES EUDAMED
- GMDN Term
- Orthopaedic bone staple, non-adjustable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic bone staple, non-adjustable
Elite by Synthes — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone staple, non-adjustable.
- MotoCLIP/HiMAX Step Staple — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Step Boss — Biomedical Enterprises, Inc. · Class II
- Speed — Biomedical Enterprises, Inc. · Class II
- MotoBAND™ CP DynaForce® MTP — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- JAWS Nitinol Staple System — Paragon 28 · Class II
- GEO Staple System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class II
- CARINA — HNM TOTAL RECON LLC · Class II
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Synthes
Sources (2)
- FDA UDI f3581216-a00a-46cb-af3b-ca5c2eec40db 36 fields · synced Jun 19, 2026
- EUDAMED 3f1e82e2-640d-42a3-bce8-86cca661b425 61 fields · synced Jun 19, 2026