Identity
- Trade Name
- DISPOSABLE SUPER CUT FINE NEEDLE FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, reusable FDA UDI
- Device Name
- DISPOSABLE SUPER CUT TUNGSTEN CARBIDE MODIFIED FINE NEEDLE WITH HEAT SHRINK SET FDA UDI
- Model / Reference
- ES61HS FDA UDI
- Description
- DISPOSABLE SUPER CUT TUNGSTEN CARBIDE MODIFIED FINE NEEDLE WITH HEAT SHRINK SET FDA UDI
Identifiers
- Catalog Number
- ES61HS FDA UDI
- Primary DI / UDI-DI
- 00192896009417 FDA UDI
- 510(k) Number
- K942986 FDA UDI
- FDA Product Code
- HGI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4120 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
Dimensions & Sizes
- Size
- Length — 4.5 Millimeter FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, reusable
Disposable Super Cut Fine Needle by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, reusable.
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- Cameron-Miller — Cameron-Miller, Inc. · Class II
Cleared under the same submission
K942986 also covers:
- Bovie — Gyrus Acmi, Inc.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 9c4aef3c-f5f7-4246-b5b0-69521d71afac 37 fields · synced May 30, 2026