Identity
- Trade Name
- COLORADO EUDAMEDFDA UDI
- Generic Name
- Electrosurgical cable adaptor FDA UDI
- Device Name
- Colorado Needle Adapter EUDAMEDADAPTER CHUCK FDA UDI
- Model / Reference
- AC2000 EUDAMEDFDA UDI08858251005914TX EUDAMED
- Description
- ADAPTER CHUCK FDA UDI
Identifiers
- Catalog Number
- AC2000 FDA UDI
- Primary DI / UDI-DI
- 04546540000057 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251005914TX EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrosurgical cable adaptor FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Colorado by Stryker Leibinger — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
- Stryker Leibinger
Sources (2)
- FDA UDI fa84d3d9-5eb6-4bf3-97ff-4148d5b52dc1 35 fields · synced Sep 30, 2026
- EUDAMED 99049e6c-7686-4494-b37c-c17e7160b563 61 fields · synced Sep 30, 2026