FDA.reportPublic FDA data

PRINCETON

Primary DI
00810158214194
Brand
PRINCETON
Company
Princeton Medical Group, Inc.
Model
67220-38
Device description
"DILATOR-CATHETER WALTHER FEMALE 38 FR. 5.25"""
Published
2025-01-27
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
00810158214194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810158214194008101582141948101582141940810158214194

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary dilatorA surgical instrument used during a surgical procedure to enlarge or open/clear a pulmonary structure. 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
00810158219762PRINCETON11116-182026-05-20
00810158219779PRINCETON19995-382026-05-20
00810158219786PRINCETON89139-172026-05-20
00810158219793PRINCETON33654-102026-05-20
00810158219809PRINCETON45206-162026-05-20
00810158219816PRINCETON47471-042026-05-20
00810158219748PRINCETON45350-702026-05-19
00810158219755PRINCETON34533-172026-05-19
00810158219625PRINCETON25407-122026-04-22
00810158219687PRINCETON45706-352026-04-22
00810158219694PRINCETON45766-352026-04-22
00810158219700PRINCETON45766-402026-04-22
00810158219717PRINCETON45766-452026-04-22
00810158219724PRINCETON45766-502026-04-22
00810158219731PRINCETON75600-132026-04-22
00810158214538PRINCETON43602-032026-04-21
00810158219465PRINCETON11304-172026-04-21
00810158219472PRINCETON61025-202026-04-21
00810158219489PRINCETON61037-202026-04-21
00810158219496PRINCETON47223-022026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G412PH60880MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60890MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60900MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60910MR PHACOCrestpoint Management LimitedHNW2025-05-27
00810158215191PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
00810158215207PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
00810158215214PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
G2231132500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNW2025-05-13
00810158215078PRINCETONPrinceton Medical Group, Inc.HNW2025-05-06
00194613010904MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-03-21
00810158214514PRINCETONPrinceton Medical Group, Inc.HNW2025-03-13
00810158214521PRINCETONPrinceton Medical Group, Inc.HNW2025-03-13
00840183529758BR Surgical, LLCBR Surgical, LLCHNW2025-02-14
00757770410668Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770414949Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770419166Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20