Identity
- Trade Name
- A&E Medical / Myo/Clip FDA UDI
- Generic Name
- Electrical-only medical device connection cable, single-use FDA UDI
- Device Name
- Myo/Clip, 120 per box of each component FDA UDI
- Model / Reference
- 019-511 FDA UDI
- Description
- Myo/Clip, 120 per box of each component FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20841291105357 FDA UDI
- 510(k) Number
- K930528 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
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
Ethylene Oxide FDA UDI
Category: Electrical-only medical device connection cable, single-use
A&E Medical / Myo/Clip by A & E Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K930528 also covers:
- A&E Medical / Adapter Plug — A & E MEDICAL CORPORATION
- A&E Medical / Adapter Plug — A & E MEDICAL CORPORATION
- A&E Medical / Disposable Bipolar Cords — A & E MEDICAL CORPORATION
- A&E Medical / Disposable Laparoscopic Cords — A & E MEDICAL CORPORATION
- A&E Medical / Disposable Laparoscopic Cords — A & E MEDICAL CORPORATION
- A&E Medical / Disposable Laparoscopic Cords — A & E MEDICAL CORPORATION
- A&E Medical / Disposable Laparoscopic Cords — A & E MEDICAL CORPORATION
- A&E Medical / Myo/Clip — A & E MEDICAL CORPORATION
- A&E Medical / Raney Clips — A & E MEDICAL CORPORATION
- A&E Medical / Raney Clips — A & E MEDICAL CORPORATION
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
- A & E Medical Corporation
Sources (1)
- FDA UDI 60a28ac6-842e-43fc-8395-ff60b448d543 34 fields · synced May 30, 2026