Identity
- Trade Name
- TenderTrode Plus™ FDA UDI
- Generic Name
- Cable/lead/sensor/probe cover, non-sterile FDA UDI
- Device Name
- Thermal Probe Cover 20/pouch, 10 pouches/case, 500 per case FDA UDI
- Model / Reference
- A10008 FDA UDI
- Description
- Thermal Probe Cover 20/pouch, 10 pouches/case, 500 per case FDA UDI
Identifiers
- Catalog Number
- A10008 FDA UDI
- Primary DI / UDI-DI
- 10813150020579 FDA UDI
- 510(k) Number
- K915831 FDA UDI
- FDA Product Code
- FMT FDA UDI
- GMDN Term
- Cable/lead/sensor/probe cover, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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: Cable/lead/sensor/probe cover, non-sterile
TenderTrode Plus™ by Graphic Controls Acquisition Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K915831 also covers:
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
- Graphic Controls Acquisition Corp
Sources (1)
- FDA UDI c5051d7b-79a3-421a-9ab3-068d9d9306f5 36 fields · synced May 31, 2026