FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158212077
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
47124-50
Device description
"NASAL SPECULUM COTTLE 50MM 5.5"""
Published
2024-04-26
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
00810158212077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158212077008101582120778101582120770810158212077

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
00810238290001PRINCETON09525-222026-09-22
00810238290018PRINCETON41085-202026-09-22
00810238290025PRINCETON33711-202026-09-22
00810238290049PRINCETON19128-182026-09-22
00810238290063PRINCETON13221-182026-09-22
00810238290070PRINCETON33476-982026-09-22
00810238290087PRINCETON11187-122026-09-22
00810238290094PRINCETON45010-302026-09-22
00810238290100PRINCETON45010-452026-09-22
00810238290117PRINCETON45010-552026-09-22
00810238290124PRINCETON45010-652026-09-22
00850088713756PRINCETON33707-172026-09-22
00850088713763PRINCETON33474-972026-09-22
00850088713770PRINCETON41250-152026-09-22
00850088713787PRINCETON41297-102026-09-22
00850088713824PRINCETON19234-202026-09-22
00850088713862PRINCETON19803-162026-09-22
00850088713886PRINCETON33950-012026-09-22
00850088713893PRINCETON03340-502026-09-22
00850088713916PRINCETON11110-112026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955SPCM1Paul BandittTerlain Enterprises, Inc.EPY2026-09-25
00190776432256MillenniumAvalign Technologies, Inc.EPY2026-09-24
00810238290094PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290100PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290117PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290124PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
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