FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158217515
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
45019-60
Device description
EAR SPECULUM FARRIOR OVAL 6 X 7MM
Published
2025-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810158217515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158217515008101582175158101582175150810158217515

GMDN Terms#

Term, Definition table
TermDefinition
Ear speculum, reusableA rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012857277
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
00810158215955PRINCETON45190-012026-08-25
00810158217409PRINCETON41161-042026-08-25
00850088713565PRINCETON34536-032026-08-25
00850088713572PRINCETON34815-062026-08-25
00850088713589PRINCETON33475-012026-08-25
00850088713596PRINCETON11174-122026-08-25
00850088713602PRINCETON75450-132026-08-25
00850088713619PRINCETON11102-202026-08-25
00850088713626PRINCETON51131-222026-08-25
00850088713220PRINCETON93216-162026-08-14
00850088713237PRINCETON93190-162026-08-14
00850088713244PRINCETON47474-022026-08-14
00850088713251PRINCETON17170-302026-08-14
00850088713299PRINCETON34547-232026-08-14
00850088713305PRINCETON19310-052026-08-14
00850088713312PRINCETON19694-012026-08-14
00850088713329PRINCETON19694-022026-08-14
00850088713336PRINCETON19694-032026-08-14
00850088713343PRINCETON19802-162026-08-14
00850088713350PRINCETON09283-152026-08-14

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