Identity
- Trade Name
- IMPULSION FDA UDI
- Generic Name
- Orthopaedic implant/instrument dismantling device FDA UDI
- Device Name
- KEY FDA UDI
- Model / Reference
- 87M EUDAMEDFDA UDIHead removal key EUDAMED
- Description
- KEY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663394170871 EUDAMEDFDA UDI
- Basic UDI-DI
- 36633940080R2 EUDAMED
- 510(k) Number
- K093894 FDA UDI
- FDA Product Code
- EFA FDA UDI
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
- GMDN Term
- Orthopaedic implant/instrument dismantling device FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- France 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
Category: Orthopaedic implant/instrument dismantling device
Impulsion by Etablissements Anthogyr — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic implant/instrument dismantling device.
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- Avenue T — Ldr Spine USA · Class I
- OSS™ — Biomet Orthopedics, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Etablissements Anthogyr
Sources (2)
- FDA UDI 63fe2218-1137-48e9-b62e-e38727e48999 34 fields · synced Jun 20, 2026
- EUDAMED 2fa2dc46-6f54-4f58-8feb-472471f82769 61 fields · synced Jun 20, 2026