Identity
- Trade Name
- Roydent FDA UDI
- Generic Name
- Injectate temperature probe FDA UDI
- Device Name
- CHEMLOCK MINI KIT FDA UDI
- Model / Reference
- 709 FDA UDI
- Description
- CHEMLOCK MINI KIT FDA UDI
Identifiers
- Catalog Number
- 709 FDA UDI
- Primary DI / UDI-DI
- D8097091 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Injectate temperature probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 6 Milliliter FDA UDI
Category: Injectate temperature probe
Roydent by Roydent Dental Products Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Injectate temperature probe.
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- IN-LINE INJECTATE SENSOR CABLE-SP4046 — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- IN-LINE INJECTATE SENSOR CABLE-SP4045 — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
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
- Roydent Dental Products Inc
Sources (1)
- FDA UDI 65e4f4fd-f256-43a3-b435-2c0410037866 37 fields · synced Jun 8, 2026