FDA.reportPublic FDA data

PRINCETON

Primary DI
00810238290100
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
45010-45
Device description
EAR SPECULUM HARTMANN 4.5MM
Published
2026-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00810238290100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810238290100008102382901008102382901000810238290100

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
012857277
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810238290179PRINCETON71715-082026-10-29
00810238290186PRINCETON61161-142026-10-29
00810238290193PRINCETON09161-232026-10-29
00810238290209PRINCETON13515-232026-10-29
00810238290247PRINCETON55520-202026-10-29
00810238290131PRINCETON45709-302026-10-23
00810238290155PRINCETON71710-062026-10-23
00810238290162PRINCETON71710-122026-10-23
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
00810238290117PRINCETON45010-552026-09-22
00810238290124PRINCETON45010-652026-09-22
00850088713756PRINCETON33707-172026-09-22
00850088713763PRINCETON33474-972026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776440558V. MuellerAvalign Technologies, Inc.EPY2026-11-03
04250676750662Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750679Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750686Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750693Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750709Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750716Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750723Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750730Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750761Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750778Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750785Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750792Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750808Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750945Tieck-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750952Tieck-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750969Vienna model nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750976Hartmann-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750983Hartmann-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750990Hartmann-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751003Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751010Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751027Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751041Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751058Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751065Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751072Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751089Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751096Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751102Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28