Identity
- Trade Name
- DiamondTemp™ Generator Connection Box E FDA UDI
- Generic Name
- Electrosurgical cable adaptor FDA UDI
- Device Name
- BOX CEDTGCB100 CONNECTION BOX US FDA UDI
- Model / Reference
- CEDTGCB100 FDA UDI
- Description
- BOX CEDTGCB100 CONNECTION BOX US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000442842 FDA UDI
- PMA Number
- P200028 FDA UDI
- FDA Product Code
- OAE FDA UDI
- GMDN Term
- Electrosurgical cable adaptor FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical cable adaptor
DiamondTemp™ Generator Connection Box E by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical cable adaptor.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- VESALIUS bipolar connector for scissors — TELEA ELECTRONIC ENGEENERING SRL · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- Valleylab — Covidien LP · Class II
- COOLIEF* — Avanos Medical, Inc. · Class II
- Nimbus Probe Adapter Cable — Stratus Medical LLC · Class II
Cleared under the same submission
P200028 also covers:
- DiamondTemp™ EGM cable — MEDTRONIC NAVIGATION, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Bidirectional Ablation Catheter — MEDTRONIC, INC.
- DiamondTemp™ Catheter-to-RFG Cable — MEDTRONIC, INC.
- DiamondTemp™ Catheter-to-RFG Cable — MEDTRONIC, INC.
- DiamondTemp™ FASTR RF Generator — MEDTRONIC, INC.
- DiamondTemp™ FASTR RF Generator — MEDTRONIC, INC.
- DiamondTemp™ FASTR RF Generator — MEDTRONIC, INC.
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 0b9ae022-1dcd-40d5-9cdb-00c44bc1a771 36 fields · synced May 30, 2026