Identity
- Trade Name
- Eikon LT Adapt Smoke Evacuation FDA UDI
- Generic Name
- Fibreoptic retractor handle FDA UDI
- Device Name
- Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. FDA UDI
- Model / Reference
- A175TSE FDA UDI
- Description
- Intended to provide tissue retraction and surgical site illumination from a high intensity light source. Additionally, the device is intended to remove smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. FDA UDI
Identifiers
- Catalog Number
- A175TSE FDA UDI
- Primary DI / UDI-DI
- 00816728021506 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Fibreoptic retractor handle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Dimensions & Sizes
- Size
- Length — 175 Millimeter FDA UDI
Category: Fibreoptic retractor handle
Eikon LT Adapt Smoke Evacuation by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Fibreoptic retractor handle.
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- ELMED — ELMED INCORPORATED · Class I
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI cb63dad9-60ed-45c2-87ec-3ba1f170fdda 36 fields · synced Jun 8, 2026