FDA.reportPublic FDA data

American Eagle Instruments

Primary DI
00841013119866
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AEEP23/UNC12RYX
Device description
Explorer 23 / UNC12 (Yellow) Black Hndl (3/8)
Published
2023-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIXProbe, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841013119866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013119866008410131198668410131198660841013119866

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical probe, reusableA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-551-5172customerservice@am-eagle.com

Regulatory Flags#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791021510DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791021511B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102151H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102157H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102158H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102159H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910217U150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791021NH0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910223C1150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G87910223GF0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791022NH0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791023AU150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G8791026QW0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP02H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CP1150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN100DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102CPN150DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102GFP0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102W11B0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
G879102WGF0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIX2026-08-08
B382SD19300Surgical DirectSurgical Direct, Inc.EIX2026-07-31
08057639712677Needle tip - BLKMC BIO SRLEIX2026-07-28
08057639712684Needle tipMC BIO SRLEIX2026-07-28
00850083275693Intrace USAPILOTIS TECH LLCEIX2026-07-03
10856364008100Florida ProbeFlorida Probe CorporationEIX2023-08-08
07898506811861QuinelatoSchobell Industrial LtdaEIX2022-12-08
07898506811878QuinelatoSchobell Industrial LtdaEIX2022-12-08