Identity
- Trade Name
- Ace + 7 FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed FDA UDI
- Device Name
- HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS FDA UDI
- Model / Reference
- HARH23R FDA UDI
- Description
- HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS FDA UDI
Identifiers
- Catalog Number
- HARH23R FDA UDI
- Primary DI / UDI-DI
- 10888551045230 FDA UDI
- 510(k) Number
- K182272 FDA UDI
- FDA Product Code
- NLQ FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not 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
Ethylene Oxide FDA UDI
Ace + 7 by Sterilmed, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 U | Pending data |
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Manufacturer
- Manufacturer
- Sterilmed, Inc.
Sources (1)
- FDA UDI 5f587691-28b9-4684-bc9e-14e5fe9cc5fb 37 fields · synced May 31, 2026