FDA.reportPublic FDA data

Dynamic DIAGNOSTICS, INC

Primary DI
00851255007111
Brand
Dynamic DIAGNOSTICS, INC
Company
BIOPROTECH INC.
Model
PEN41
Device description
Slim, Rocker, 2.5” Non-stick Ceramic or FEP Coated Blade, 10 Ft(3M) or 16 Ft(5M) Cable, Holster, Blister package
Published
2025-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092732000PROPENCIL ESU PENCILBio Protech, Inc.2009-11-25GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851255007118PackageGS14In Commercial Distribution
20851255007115PackageGS125In Commercial Distribution
00851255007111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085125500711810851255007118
2085125500711520851255007115
00851255007111008512550071118512550071110851255007111

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, single-useA rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
688460539
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809083949129TELECTRODET8172026-04-30
08809083949136TELECTRODET817A2026-04-30
00858563006256MAX-IFIF40002025-10-13
08809083946883PROPLATE9572C2025-05-20
18809083946880PROPLATE9572C2025-05-20
00815842021386IMCO2030-IMC2025-05-16
10815842021383IMCO2030-IMC2025-05-16
00851255007043Dynamic DIAGNOSTICS, INCPEN112025-03-12
00851255007098Dynamic DIAGNOSTICS, INCPEN312025-03-12
00851255007104Dynamic DIAGNOSTICS, INCPEN212025-03-12
00851255007128Dynamic DIAGNOSTICS, INCP9551F2025-03-12
00851255007135Dynamic DIAGNOSTICS, INCP9552F2025-03-12
00851255007142Dynamic DIAGNOSTICS, INC9551F2025-03-12
00851255007159Dynamic DIAGNOSTICS, INC9552F2025-03-12
00851255007166Dynamic DIAGNOSTICS, INCP9551-RF2025-03-12
20851255007047Dynamic DIAGNOSTICS, INCPEN112025-03-12
00851255007050Dynamic DIAGNOSTICS, INCPEN11NS2025-03-12
00851255007067Dynamic DIAGNOSTICS, INCPEN31NS2025-03-12
00851255007074Dynamic DIAGNOSTICS, INCPEN21NS2025-03-12
00851255007081Dynamic DIAGNOSTICS, INCPEN41NS2025-03-12

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Primary DI, Brand, Company table
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00846338006235Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
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