Identity
- Trade Name
- ACCULAN EUDAMEDFDA UDI
- Generic Name
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
- Device Name
- ACCULAN accessories EUDAMEDAcculan 3Ti battery removal device FDA UDI
- Model / Reference
- GA679 EUDAMEDFDA UDI
- Description
- Acculan 3Ti battery removal device FDA UDI
Identifiers
- Catalog Number
- GA679 FDA UDI
- Primary DI / UDI-DI
- 04038653444847 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000002962G EUDAMED
- FDA Product Code
- MOQ FDA UDI
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMED
- GMDN Term
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Acculan by Aesculap, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Aesculap, Inc.
Sources (2)
- FDA UDI 89bf02de-9c58-4334-8885-8caf41c6f3eb 35 fields · synced Oct 8, 2026
- EUDAMED f7622a90-c3c8-412a-8d22-7043da9cdad5 61 fields · synced Oct 8, 2026