Identity
- Trade Name
- DiamondTemp™ EGM cable FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- EGM CABLE CEDTEGM100 DIAMONDTEMP US FDA UDI
- Model / Reference
- CEDTEGM100 FDA UDI
- Description
- EGM CABLE CEDTEGM100 DIAMONDTEMP US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000455699 FDA UDI
- PMA Number
- P200028 FDA UDI
- FDA Product Code
- OAE FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrical-only medical device connection cable, reusable
DiamondTemp™ EGM cable by Medtronic Navigation, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrical-only medical device connection cable, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Guenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbH · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Connection Cable — Shenzhen Keborui Electronics Co., Ltd · Class I
- TC-HEART LUNG DIN INTFC CA STOCKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
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- ECG Cable — Edan Instruments,Inc. · Class I
Cleared under the same submission
P200028 also covers:
- 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.
- DiamondTemp™ Foot Switch — 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 |
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Manufacturer
- Manufacturer
- Medtronic Navigation, Inc.
Sources (1)
- FDA UDI e33598c7-9d3e-40d5-88a5-37f77e82fe01 36 fields · synced May 30, 2026