FDA.reportPublic FDA data

American Eagle Instruments

Primary DI
00841013105623
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AEFCP2122
Device description
FORCEPS CHILD PROFILE 46L
Published
2022-07-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JEXPLIER, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEXPlier, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841013105623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013105623008410131056238410131056230841013105623

GMDN Terms#

Term, Definition table
TermDefinition
Dental rongeurA strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791050070DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-09-30
G8791052360DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-09-30
04963931274673NAYDM CORPORATIONJEX2026-09-25
04963931274680NAYDM CORPORATIONJEX2026-09-25
G8791031420DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791031430DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050010DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050140DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050660DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050670DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050680DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050810DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G879105085M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050890DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050950DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050960DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050980DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791050990DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051040DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051390DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G87910513910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051440DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051530DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791051590DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G87910515910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14
G8791052160DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDJEX2026-08-14