FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158217645
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
43139-07
Device description
"EYE SPECULUM STEVENSON 2.75"""
Published
2025-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRHTrephine, Manual, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRHTrephine, Manual, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810158217645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158217645008101582176458101582176450810158217645

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid speculum, reusableA self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841668146460BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146484BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146491BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146507BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146514BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146521BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146538BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146545BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146552BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146569BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146576BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146590BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146606BarronKATENA PRODUCTS, INC.HRH2026-06-10
05055445956165SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956172SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956189SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956196SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956202SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956219SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956226SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956233SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956240SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956257SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956264SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956271SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956288SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956295SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956301SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956318SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956325SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12