Identity
- Trade Name
- Sterile electrode's cable FDA UDI
- Generic Name
- Electrical-only medical device connection cable, single-use FDA UDI
- Model / Reference
- Sterile electrode's cable FDA UDI
Identifiers
- Catalog Number
- STR-000730-00 FDA UDI
- Primary DI / UDI-DI
- 07290114060929 FDA UDI
- 510(k) Number
- K120098 FDA UDI
- FDA Product Code
- GZL FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
MR Unsafe FDA UDI
Category: Electrical-only medical device connection cable, single-use
Sterile electrode's cable by Alpha Omega Engineering Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K120098 also covers:
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- Cannula — Alpha Omega Engineering Corp.
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- Cannula — Alpha Omega Engineering Corp.
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- Cannula — Alpha Omega Engineering Corp.
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- NeuroNav Input Cable — Alpha Omega Engineering Corp.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alpha Omega Engineering Corp.
Sources (2)
- FDA UDI 1bfe9fb5-ba59-4a7f-8e4c-a0523d1f0eb8 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 28, 2026