Identity
- Trade Name
- STERILE Mapping Probe FDA UDI
- Generic Name
- Intramuscular diaphragm/phrenic nerve electrical stimulation system electrode, return FDA UDI
- Model / Reference
- 21-0001-99 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852184003090 FDA UDI
- FDA Product Code
- OIR FDA UDI
- GMDN Term
- Intramuscular diaphragm/phrenic nerve electrical stimulation system electrode, return FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
Category: Intramuscular diaphragm/phrenic nerve electrical stimulation system electrode, return
STERILE Mapping Probe by Synapse Biomedical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intramuscular diaphragm/phrenic nerve electrical stimulation system electrode, return.
- STERILE Indifferent Electrode — Synapse Biomedical, Inc. · Class III
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
- Synapse Biomedical, Inc.
Sources (1)
- FDA UDI 62eb2343-1c43-4d8a-a59d-b68792a39a42 32 fields · synced Jun 6, 2026