FDA.reportPublic FDA data

American Eagle Instruments

Primary DI
00841013116025
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
MM13-14X
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

Product Codes#

Code, Name table
CodeName
EMSCURETTE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMSCurette, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841013116025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013116025008410131160258410131160250841013116025

GMDN Terms#

Term, Definition table
TermDefinition
Infant scale, electronicAn electrically-powered device designed to measure the weight of an infant, particularly a newborn, or to monitor weight changes, e.g., during critical care procedures. It typically consist of a weight tray, a flexure plate or bending beam, an electronic transducer, and an analogue or digital display; it may include markings to also measure infant length. The device is also known as paediatric or baby scale.

Sterilization Methods#

Method table
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783007466Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007473Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007534Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007541Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007558Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007565Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007572Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007596Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007602Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007619Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007671Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007756Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008159Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008166Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008173Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008197Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008210Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008227Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008234Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008241Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008258Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00840018674547Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-14
00840018674554Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-14
00840018674561Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-14
00840018674493Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-12
00840018674509Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-12
04251436943843KOHLERKohler Medizintechnik GmbHEMS2026-03-12
00840018674295Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-11
00840018674301Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-11
00840018674318Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-11