FDA.reportPublic FDA data

American Eagle Instruments

Primary DI
00841013116513
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
NYU3
Device description
NYU 3 HATCHET (10-97-7-15)
Published
2024-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EMQHOE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMQHoe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841013116513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013116513008410131165138410131165130841013116513

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal hoeA hand-held manual dental instrument with a small blade at an acute angle (e.g., 90 degrees) to its stem intended to be used with a pulling action to remove gross amounts of supragingival calculus, and some subgingival calculus, in large wide-open pockets where the gingival tissue is soft and easily cleaned. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790776850
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840018661318Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMQ2026-01-28
D928400512RD0CHISEL 7-10 D/E ROUND HANDLEW.H. Holden, Inc.EMQ2026-01-06
10889950133603Hu-FriedyHU-FRIEDY MFG. CO., LLCEMQ2025-12-19
00841336108738Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMQ2025-11-11
00841013116537American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EMQ2024-11-06
10889950023102Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
10889950025526Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
10889950092887Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
10889950093693Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
10889950023096Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950023294Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950025489Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950025496Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950025588Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950025595Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950030636Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950030643Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950030650Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950030667Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033194Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033200Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033361Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033378Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950089863Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950091897Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950092764Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950092849Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950092979Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950096922Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950097196Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07