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External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima FDA UDI
- Generic Name
- Dermatological laser beam guiding handpiece FDA UDI
- Device Name
- External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima FDA UDI
- Model / Reference
- KT77911 FDA UDI
- Description
- External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima FDA UDI
Identifiers
- Catalog Number
- KT77911 FDA UDI
- Primary DI / UDI-DI
- 00817495024554 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological laser beam guiding handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dermatological laser beam guiding handpiece
External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Candela Corporation
Sources (1)
- FDA UDI df41653a-54f1-42ec-ba02-bd40bd06de76 35 fields · synced Jun 8, 2026