Identity
- Trade Name
- Bleph kit FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- Bleph Kit FDA UDI
- Model / Reference
- SBK-01 FDA UDI
- Description
- Bleph Kit FDA UDI
Identifiers
- Catalog Number
- SBK-01 FDA UDI
- Primary DI / UDI-DI
- 00810026183775 FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Commercial Distribution
- 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
Yes
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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Electrical-only medical device connection cable, reusableOpen-surgery electrosurgical electrode, monopolar, single-useOpen-surgery electrosurgical handpiece/electrode, bipolar, single-useElectrosurgical return electrode, single-use
Bleph kit by Soniquence, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Soniquence, LLC
Sources (1)
- FDA UDI a388b996-b18d-416b-b223-108f90381804 34 fields · synced May 31, 2026