FDA.reportPublic FDA data

Dannik

Primary DI
10850013527356
Brand
Dannik
Company
Dannik LLC
Model
DMP5905
Device description
Disposable Monopolar 5mm x 33cm Curved Maryland Dissector, Non-Ratcheting
Published
2023-01-21
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850013527356PrimaryGS10
00850013527359Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001352735610850013527356
00850013527359008500135273598500135273590850013527359

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useAn electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.

Regulatory Flags#

DUNS number
117407001
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850013527929True5mm™ SUPERBAG PNI0120PNI01202026-03-25
10850013527974EXTENDNI0100NI01002026-03-25
10850013527035DannikDMP5910F2023-01-21
10850013527042DannikDMP59202023-01-21
10850013527059DannikDMP59452023-01-21
10850013527066DannikDMP59502023-01-21
10850013527349DannikDMP59252023-01-21
10850013527394PMI LAPSYSTEM™LSDLS-33MMETZLSDLS-33MMETZ2024-10-23
10850013527417PMI LAPSYSTEM™LSDLS-33MYLDLSDLS-33MYLD2024-10-23
10850013527448PMI LAPSYSTEM™LSDLS-33BBCKLSDLS-33BBCK2024-10-23
10850013527783PMI LAPSYSTEM™LSDLS-33CVMETZLSDLS-33CVMETZ2024-05-30
10850013527806PMI LAPSYSTEM™LSDLS-33GRASPERLSDLS-33GRASPER2024-10-23
10850013527790SOLOBAGPPI0280PPI02802025-06-27
10850013527950DANNIKPI0280PI02802025-06-27
00850013527793SOLOBAGPPI0280PPI02802025-06-27
00850013527953DANNIKPI0280PI02802025-06-27
00850013527397PMI LAPSYSTEM™LSDLS-33MMETZLSDLS-33MMETZ2024-10-23
00850013527410PMI LAPSYSTEM™LSDLS-33MYLDLSDLS-33MYLD2024-10-23
00850013527441PMI LAPSYSTEM™LSDLS-33BBCKLSDLS-33BBCK2024-10-23
00850013527809PMI LAPSYSTEM™LSDLS-33GRASPERLSDLS-33GRASPER2024-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327693287MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693294MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693362MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693379MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693386MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693393MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693409MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693416MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693423MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693430MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693447MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693454MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693461MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693478MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693485MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693492MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693508MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693515MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693522MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693539MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693546MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693553MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693560MalisSTRYKER CORPORATIONGEI2026-02-25
07613327693577MalisSTRYKER CORPORATIONGEI2026-02-25
07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548167NeptuneSTRYKER CORPORATIONGEI2024-12-10