FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158215207
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
RD-1004
Device description
EYE SPECULUM BARRAQUER WITH SOLID BLADE; BLADE LENGTH 15MM
Published
2025-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNWDilator, Lachrymal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNWDilator, LachrymalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810158215207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158215207008101582152078101582152070810158215207

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
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
00724995319830V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319847V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319878V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319885V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319892V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319908V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319915V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319922V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319939V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319946V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319953V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319960V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319977V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00724995319984V. MuellerSTERIS Deutschland GmbHHNW2026-09-25
00190776421823MillenniumAvalign Technologies, Inc.HNW2026-06-24
04251047934155Gerten Dilator for the Easy Liquid Bubble DMEKA1 Medical GmbHHNW2026-06-09
00810158214538PRINCETONPrinceton Medical Group, Inc.HNW2026-04-21
00840319758892Hayden MedicalHayden Medical, Inc.HNW2026-03-31
00041533986560Bruder KarpeckiThe Hilsinger Company Parent, LlcHNW2025-11-21
00190776411619MillenniumAvalign Technologies, Inc.HNW2025-09-24
00194613010836MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010867MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010874MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613051501MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613083168MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00190776400873MillenniumAvalign Technologies, Inc.HNW2025-06-05
G412PH60850MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH6085T0MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60860MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60870MR PHACOCrestpoint Management LimitedHNW2025-05-27