FDA.report

Plak-Vac

Primary DI
B23923441
Brand
Plak-Vac
Company
TRADEMARK MEDICAL, L.L.C.
Model
2344
Catalog number
2344
Device description
Plak-Vac custom kit
Published
2018-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NXZDental Hygiene Kit

Product Code Classifications

CodeDeviceSpecialtyClass
NXZDental Hygiene KitDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B23923441PackageHIBCC24In Commercial Distribution
B23923440PrimaryHIBCC0

GMDN Terms

TermDefinition
Oral care kit, single-useA collection of various devices and supplies used for a patient's oral hygiene. It typically includes an antiseptic applicator swab, a pre-treated toothbrush, mouth swabs, and a mouthwash/oral moisturizer. Its use will improve the physical condition of the oral cavity and may help reduce the incidence of patient infection. It is typically applied by nursing staff in hospitals and institutions, or attendants in home care settings. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
024113805
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B23931151Plak-Vac311531152026-01-08
B23930871Plak-Vac308730872024-09-09
B23931081Plak-Vac310831082024-08-12
B23931061Plak-Vac310631062024-08-05
B23931071Plak-Vac310731072024-08-05
B23930021Plak-Vac300230022024-07-18
B23931021Plak-Vac310231022024-07-18
B23931051Plak-Vac310531052024-07-18
B23930901Plak-Vac309030902024-07-02
B23931041Plak-Vac310431042024-07-02
B23931031Plak-Vac310331032024-06-21
B23930731Plak-Vac307330732024-04-17
B23930941Plak-Vac309430942024-04-17
B23930951Plak-Vac309530952024-04-17
B23930881Plak-Vac308830882024-02-20
B23930961Plak-Vac309630962024-02-20
B23930971Plak-Vac309730972024-02-20
B23930981Plak-Vac309830982024-02-20
B23930841Plak-Vac308430842024-02-15
B23930851Plak-Vac308530852024-02-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06956748709443Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXZ2026-02-04
B23931151Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2026-01-08
00850035489055Oral Relief KitzOrthonu LLCNXZ2025-04-27
B23930871Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-09-09
B23931081Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-12
B23931061Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23931071Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23930021Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931021Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931051Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23930901Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931041Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931031Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-06-21
B23930731Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930941Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930951Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930881Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-02-20
B23930961Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-02-20
B23930971Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-02-20
B23930981Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-02-20
B23930841Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-02-15
B23930851Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-02-15
B23930911Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-01-30
B23930921Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-01-30
B23930931Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-01-30
B23930830Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2023-10-30
B23930861Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2023-10-23
B23930771Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2023-09-06
B23930751Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2023-08-07
B23930741Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2023-06-02