FDA.reportPublic FDA data

American Eagle Instruments

Primary DI
00841013124792
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AESCCON
Catalog number
AESCCON
Device description
Galaxie Surgical Container Cassette, tooth design
Published
2026-02-12
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
00841013124792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013124792008410131247928410131247920841013124792

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
00841013104015American Eagle InstrumentsAECP1CFSMAECP1CFSM2022-07-24
00841013108297American Eagle InstrumentsAEHA10-10OA2022-05-23
00841013108303American Eagle InstrumentsAEHA10-112022-05-23
00841013108310American Eagle InstrumentsAEHA11-11OA2022-05-23
00841013108358American Eagle InstrumentsAEHA17-182022-05-23
00841013108365American Eagle InstrumentsAEHA8-8OA2022-05-23
00841013108372American Eagle InstrumentsAEHA8-92022-05-23
00841013109621American Eagle InstrumentsAEPEM92022-05-23
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
00841013124808American Eagle InstrumentsAECAGRAILAECAGRAIL2026-02-12
00841013124815American Eagle InstrumentsAECRAILAECRAIL2026-02-12

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