FDA.reportPublic FDA data

STRADIS HEALTHCARE

Primary DI
M75220052BFH0
Brand
STRADIS HEALTHCARE
Company
STRADIS MEDICAL, LLC
Model
20052BFH
Device description
CUSTOM DENTAL KIT PROCEDURE PACK
Published
2022-03-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXZDental Hygiene Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXZDental Hygiene KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M75220052BFH0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-962-2425SERVICE@STRADISHEALTHCARE.COM

Regulatory Flags#

DUNS number
174262477
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7525251811STRADIS525-1812017-04-01
M75257032650STRADIS HEALTHCARE570-32652023-01-17
M752682026NLXXXXX9STRADIS682-026NL2025-12-31
M7521697700Stradis Medical, LLC.1697702018-03-22
M752ACC25001Stradis Medical, LLC.ACC-25002018-01-29
M752ACC2500N1Stradis Medical, LLC.ACC-2500N2018-04-13
M752ACC25501Stradis Medical, LLC.ACC-25502018-01-29
M752DC1790911Stradis Medical, LLC.DC-17909-12018-05-22
M752DC51601Stradis Medical, LLC.DC-51602018-05-22
M752HCT6625TC0Stradis Medical, LLC.HCT6625TC2017-12-12
M752IM12350Stradis Medical, LLC.IM12352017-12-15
M752IM12510Stradis Medical, LLC.IM12512017-12-15
M752IM12600Stradis Medical, LLC.IM12602019-04-17
M752IMSEN101A0Stradis Medical, LLC.IM-SEN-101A2017-12-14
M752MAG30001Stradis Medical, LLC.MAG-30002018-05-30
M752ACC2550N1Stradis Medical, LLC.ACC-2550N2018-03-27
M752DC850A0Stradis Medical, LLC.DC-850A2018-04-23
M752HCT200BP0Stradis Medical, LLC.HCT200BP2017-12-07
M752HCT6057CP0Stradis Medical, LLC.HCT6057CP2017-12-12
M752HCT6186CP0Stradis Medical, LLCHCT6186CP2017-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06956748709443Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXZ2026-02-04
B23931150Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2026-01-08
B23931151Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2026-01-08
00850035489055Oral Relief KitzOrthonu LLCNXZ2025-04-27
B23930870Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-09-09
B23930871Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-09-09
B23931080Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-12
B23931081Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-12
B23931060Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23931070Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23931061Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23931071Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-08-05
B23930020Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931020Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
B23931050Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-18
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
B23930900Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931040Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23930901Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931041Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-07-02
B23931030Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-06-21
B23931031Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-06-21
B23930730Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930940Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
B23930950Plak-VacTRADEMARK MEDICAL, L.L.C.NXZ2024-04-17
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