Identity
- Trade Name
- Henry Schein FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Electrodes E20AXL 90 FDA UDI
- Model / Reference
- 9004253 FDA UDI
- Description
- Electrodes E20AXL 90 FDA UDI
Identifiers
- Catalog Number
- 9004253 FDA UDI
- Primary DI / UDI-DI
- 00304040004968 FDA UDI
- 510(k) Number
- K052622 FDA UDI
- FDA Product Code
- EKZ FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4920 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.0625 Inch FDA UDI
Category: Electrosurgical system
Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K052622 also covers:
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Macan — Macan Manufacturing
- Macan — Macan Manufacturing
- Macan — Macan Manufacturing
- Macan — Macan Manufacturing
- Macan — Macan Manufacturing
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
- Henry Schein, Inc.
Sources (1)
- FDA UDI 9c935f8f-fabc-40ab-8380-faf1468e5884 36 fields · synced May 30, 2026