Identity
- Trade Name
- EASYGO! FDA UDI
- Generic Name
- Orthopaedic trocar blade, reusable FDA UDI
- Device Name
- Trocar attachments EUDAMEDEasyGO!® II Trocar Attachment, Ø 15 mm FDA UDI
- Model / Reference
- 28163OAM EUDAMEDFDA UDI
- Description
- EasyGO!® II Trocar Attachment, Ø 15 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551350447 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048551001545U2 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- Z12109080 VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic trocar blade, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic trocar blade, reusable
Easygo! by Karl Storz GmbH & Co. KG — 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
- Karl Storz GmbH & Co. KG
Sources (2)
- FDA UDI c9401a8e-7117-4c84-90c8-ce9fae7a5624 33 fields · synced Jul 15, 2026
- EUDAMED 9639babd-19c6-41ad-9094-80052c519245 61 fields · synced Jul 15, 2026