Identity
- Trade Name
- CORE, Sumex FDA UDI
- Generic Name
- Surgical power tool hand-switch FDA UDI
- Device Name
- Handswitch FDA UDI
- Model / Reference
- 5400131000 FDA UDI
- Description
- Handswitch FDA UDI
Identifiers
- Catalog Number
- 5400-131-000 FDA UDI
- Primary DI / UDI-DI
- 04546540534132 FDA UDI
- FDA Product Code
- ERL FDA UDI
- GMDN Term
- Surgical power tool hand-switch FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4250 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical power tool hand-switch
CORE, Sumex by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- Bovie — BOVIE MEDICAL CORPORATION · Class II
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
- Stryker Corp.
Sources (1)
- FDA UDI 644ebce4-74ce-4edd-b187-e82b9a499031 36 fields · synced Jun 7, 2026