Identity
- Trade Name
- Dynamic DIAGNOSTICS, INC FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- Slim, Button, 2.5” Non-stick Ceramic or FEP Coated Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister package FDA UDI
- Model / Reference
- PEN21 FDA UDI
- Description
- Slim, Button, 2.5” Non-stick Ceramic or FEP Coated Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister package FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851255007104 FDA UDI
- 510(k) Number
- K092732 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Yes
FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Dynamic DIAGNOSTICS, INC by Bioprotech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092732 also covers:
- Bio Protech — BIO PROTECH USA, INC.
- Bio Protech — BIO PROTECH USA, INC.
- Dynamic DIAGNOSTICS, INC — BIOPROTECH INC.
- Dynamic DIAGNOSTICS, INC — BIOPROTECH INC.
- Dynamic DIAGNOSTICS, INC — BIOPROTECH INC.
- Dynamic DIAGNOSTICS, INC — BIOPROTECH INC.
- ERBE — BIOPROTECH INC.
- ERBE — BIOPROTECH INC.
- ERBE — BIOPROTECH INC.
- ERBE — BIOPROTECH INC.
- ERBE — BIOPROTECH INC.
- ERBE — BIOPROTECH 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
- Bioprotech Inc.
Sources (1)
- FDA UDI c2fee0cd-cbad-42d6-ba44-6d562e2767c4 35 fields · synced May 30, 2026