FDA.reportPublic FDA data

American Eagle Instruments

Primary DI
00841013116391
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
NYU106B
Device description
NYU BASIC EXAM CASSETTE
Published
2024-06-21
Public version status
New
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
00841013116391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013116391008410131163918410131163910841013116391

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
790776850
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
00841013124648MicroquoreAESNHMACS2026-06-26
00841013124655MicroquoreAESNHBAC2026-06-26
00841013124686MicroquoreAESMSNH2026-06-26
00841013124693MicroquoreAESMSSTT2026-06-26
00841013124709MicroquoreAESMSTCO2026-06-26
00841013124716MicroquoreAESMSSSM2026-06-26
00841013124723MicroquoreAESMSSTD2026-06-26
00841013124761American Eagle InstrumentsAEC1/4DINAEC1/4DIN 2026-02-12
00841013124778American Eagle InstrumentsAEC1/2DINAEC1/2DIN2026-02-12
00841013124785American Eagle InstrumentsAESCDINAESCDIN2026-02-12
00841013124792American Eagle InstrumentsAESCCONAESCCON2026-02-12
00841013124808American Eagle InstrumentsAECAGRAILAECAGRAIL2026-02-12
00841013124815American Eagle InstrumentsAECRAILAECRAIL2026-02-12
00841013124822American Eagle InstrumentsAECCRAILAECCRAIL2026-02-12
00841013124839American Eagle InstrumentsAESCLIPSAESCLIPS2026-02-12
00841013124846American Eagle InstrumentsAESCLIPNHAESCLIPNH2026-02-12
00841013124853American Eagle InstrumentsAESCTOOLAESCTOOL2026-02-12
00841013120459Otto LeibingerAESH512026-01-06
00841013120466Otto LeibingerAESH51E2026-01-06
00841013120473Otto LeibingerAESPUNC152026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327602241NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602296NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602302NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602326NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327602418NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663518NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663525NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663532NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663549NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663556NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
07613327663563NAStryker Leibinger GmbH & Co. KGFSM2026-07-17
18257200028177PHOENIX SFSOrthofix US LLCFSM2026-07-17
18257200028207PHOENIX SFSOrthofix US LLCFSM2026-07-17
18257200028917FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028924FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028931FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028948FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028955FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028979FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028986FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200028993FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029006FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029013FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029020FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029280FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029846FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029853FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029860FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029877FIREBIRD SFSOrthofix US LLCFSM2026-07-17
18257200029884FIREBIRD SFSOrthofix US LLCFSM2026-07-17