FDA.report

American Eagle Instruments

Primary DI
00841013108488
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AEIIKZ
Published
2022-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841013108488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013108488008410131084888410131084880841013108488

GMDN Terms

TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
790776850
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00841013120459Otto LeibingerAESH512026-01-06
00841013120466Otto LeibingerAESH51E2026-01-06
00841013120473Otto LeibingerAESPUNC152026-01-06
00841013120480Otto LeibingerAESSH52026-01-06
00841013120497Otto LeibingerAESPPR3S2026-01-06
00841013120503Otto LeibingerAESPGSP2026-01-06
00841013120510Otto LeibingerAESPGF142026-01-06
00841013120527Otto LeibingerAESPP9PA2026-01-06
00841013120534Otto LeibingerAESPWI062026-01-06
00841013120541Otto LeibingerAESPBU2026-01-06
00841013120558Otto LeibingerAESPM92026-01-06
00841013120565Otto LeibingerAESPM2026-01-06
00841013120572Otto LeibingerAESBS12026-01-06
00841013120589Otto LeibingerAESBS22026-01-06
00841013120596Otto LeibingerAESRCBA2026-01-06
00841013120602Otto LeibingerAESSCLU222026-01-06
00841013120619Otto LeibingerAESSCLU332026-01-06
00841013120626Otto LeibingerAESSCLU112026-01-06
00841013120633Otto LeibingerAESRCW2026-01-06
00841013120640Otto LeibingerAESRLAN12026-01-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07898663491562HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493108HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493467HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495263HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495270HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495751HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663496239HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663497267HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498080HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498097HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499292HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499926HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499957HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499971HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089802307HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089803113HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089803441HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089804349HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089804950HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089806367HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089806626HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807012HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807029HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089807999HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808583HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808682HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089808729HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809511HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809528HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07901089809535HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24