FDA.reportPublic FDA data

LMDental

Primary DI
06438311218144
Brand
LMDental
Company
LM-Dental
Model
6552
Device description
Servo 5E, blue, Servo Tray
Published
2020-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438311218144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438311218144064383112181446438311218144

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
401969969
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438311708775LMDental465-495XSI2026-05-25
06438311708782LMDental465-495ES2026-05-25
06438311708799LMDental465-495EST2026-05-25
06438311708805LMDental465-495ESTU2026-05-25
06438311227221LMDental128-128SDESTU2026-03-26
06438311227771LMDental128-128SDEST2026-03-26
06438311708676LMDental444-445XSIGC2026-03-23
06438311708683LMDental473-753XSIGC2026-03-23
06438311708690LMDental473-753XSI2026-03-23
06438311708706LMDental473-753ES2026-03-23
06438311708713LMDental473-753EST2026-03-23
06438311708720LMDental473-753ESTU2026-03-23
06438311708737LMDental743-753XSI2026-03-23
06438311708744LMDental743-753ES2026-03-23
06438311708751LMDental743-753EST2026-03-23
06438311708768LMDental743-753ESTU2026-03-23
06438311207407LMDental211-212AFES2025-12-31
06438311208251LMDental213-214AFES2025-12-31
06438311708034LMDental464-494DDES2025-10-10
06438311708041LMDental431-433DDES2025-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376733470CONTOUR3DALPHATEC SPINE, INC.FSM2026-09-25
00889795135278Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135285Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135292Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135308Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135339Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
10889950159221Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-09-24
00888867504059Arthrex®ARTHREX, INC.FSM2026-09-21
00888867504066Arthrex®ARTHREX, INC.FSM2026-09-21
00888867504073Arthrex®ARTHREX, INC.FSM2026-09-21
00749756400800DeRoyalDEROYAL INDUSTRIES, INC.FSM2026-09-18
08800037575166ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575173ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
10888857252820DENALI® Spinal SystemVB Spine LLCFSM2026-08-28
07640221370884TRYPTIK® TiSpineArt SAFSM2026-08-27
07613327630602MakoMAKO SURGICAL CORP.FSM2026-08-25
00724995296216V. MuellerSteris CorporationFSM2026-08-21
00724995296223V. MuellerSteris CorporationFSM2026-08-21
00724995296230V. MuellerSteris CorporationFSM2026-08-21
10888857596740NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596757NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596764NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596771NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596788NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596795NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596801NAPA Access SystemVB Spine LLCFSM2026-07-31