FDA.reportPublic FDA data

Dynamic DIAGNOSTICS, INC

Primary DI
10851255007125
Brand
Dynamic DIAGNOSTICS, INC
Company
BIOPROTECH INC.
Model
P9551F
Device description
Horizontal, Corded, Adult or Pediatric, Solid, 150x120mm, Foam
Published
2025-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K073360000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073360000PROPLATEBio Protech, Inc.2007-12-19GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851255007125PackageGS1100In Commercial Distribution
00851255007128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085125500712510851255007125
00851255007128008512550071288512550071280851255007128

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-useA dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688460539
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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
00851255007111Dynamic DIAGNOSTICS, INCPEN412025-03-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092893ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092909ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092916ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092954ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092961ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092978ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092985ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092992ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506093340ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506093449ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506093456ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
10884450452360STAR™Merit Medical Systems, Inc.GEI2026-07-28