FDA.reportPublic FDA data

Instrument Tray

Primary DI
00860014213465
Brand
Instrument Tray
Company
TETROUS, INC.
Model
TET-INS-016
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00860014213465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014213465008600142134658600142134650860014213465

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
111821928
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014213489GuidewireTET-INS-0212026-02-24
00860015151308EnFix Instrument Kit - CompleteTET-KT-0042026-02-24
00860015151315EnFix Instrument Kit - ACLTET-KT-0052026-02-24
00860015151322EnFix Instrument Kit - TACTET-KT-0062026-02-11
00860014213427Awl - Non-CuttingTET-INS-0112026-02-10
00860014213434Cutting Awl - 5.5mmTET-INS-0122026-02-10
00860014213441Cutting Awl - 4.5mmTET-INS-0132026-02-10
00860014213458Introducer ProbeTET-INS-0142026-02-10
00860014213472Pusher ProbeTET-INS-0202026-02-10
00860014213496Introducer Probe - SJTET-INS-0072026-02-10
00860014213403Introducer Probe - Flat CollarTET-INS-0052025-11-04
00860014213410Introducer Probe - Stepped CollarTET-INS-0042025-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840456220283JMUJMU DENTAL, INCFSM2026-07-07
00190446907466EF1Medshape, Inc.FSM2026-06-25
00190446907473EF1Medshape, Inc.FSM2026-06-25
00190776421724MillenniumAvalign Technologies, Inc.FSM2026-06-24
00885556924730EVOSSmith & Nephew, Inc.FSM2026-06-24
00840456200308JMUJMU DENTAL, INCFSM2026-06-23
00840456200315JMUJMU DENTAL, INCFSM2026-06-23
00840456201176JMUJMU DENTAL, INCFSM2026-06-23
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00840456214077JMUJMU DENTAL, INCFSM2026-06-23
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00840456214091JMUJMU DENTAL, INCFSM2026-06-23
00840456214107JMUJMU DENTAL, INCFSM2026-06-23
00840456214114JMUJMU DENTAL, INCFSM2026-06-23
00840456214121JMUJMU DENTAL, INCFSM2026-06-23
00840456215098JMUJMU DENTAL, INCFSM2026-06-23
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00840456215128JMUJMU DENTAL, INCFSM2026-06-23
00840456217580JMUJMU DENTAL, INCFSM2026-06-23