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
00841013120435American Eagle Instruments, Inc.AEFH3-7XPZAEFH3-7XPZ2025-02-18
00841013120442American Eagle Instruments, Inc.AEFH5-11XPZAEFH5-11XPZ2025-02-18
00841013101892American Eagle InstrumentsAEB2-30BEFAEB2-30BEF2022-07-24
00841013102059American Eagle InstrumentsAEBM1TNAEBM1TN2022-07-24
00841013109607American Eagle InstrumentsAEPBP-2AEPBP-22022-07-24
00841013101878American Eagle InstrumentsAEB21BAAEB21BA2022-05-23
00841013101908American Eagle InstrumentsAEB26-27BAEB26-27B2022-05-23
00841013101915American Eagle InstrumentsAEB26-28BFAEB26-28BF2022-05-23
00841013101922American Eagle InstrumentsAEB26-29BFAEB26-29BF2022-05-23
00841013101939American Eagle InstrumentsAEB26-30BFAEB26-30BF2022-05-23
00841013101946American Eagle InstrumentsAEB26-30BFTNAEB26-30BFTN2022-05-23
00841013101953American Eagle InstrumentsAEB26-30BFTNZAEB26-30BFTNZ2022-05-23
00841013102004American Eagle InstrumentsAEBH6AEBH62022-05-23
00841013102011American Eagle InstrumentsAEBH7AEBH72022-05-23
00841013102066American Eagle InstrumentsAEBM1TNZAEBM1TNZ2022-05-23
00841013102073American Eagle InstrumentsAEBNYUB-1AEBNYUB-12022-05-23
00841013102080American Eagle InstrumentsAEBPFI18BAEBPFI18B2022-05-23
00841013102097American Eagle InstrumentsAEBPFI21AAEBPFI21A2022-05-23
00841013102103American Eagle InstrumentsAEBPP18AEBPP182022-05-23
00841013108600American Eagle InstrumentsAEMCB21ATNZ2022-05-23

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