FDA.reportPublic FDA data

Bruder Karpecki

Primary DI
00041533986560
Brand
Bruder Karpecki
Company
The Hilsinger Company Parent, Llc
Model
98656
Catalog number
1301466
Device description
KARPECKI PUNCTAL DILATOR- DOUBLE ENDED
Published
2025-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00041533986560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00041533986560000415339865600415339865600041533986560

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal dilator, single-useA sterile, hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-955-6544qara@hilcovision.com

Regulatory Flags#

DUNS number
118449190
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
00041533986522Bruder Karpecki9865213014872026-05-22
00041533986119Bruder9861110942312026-02-25
00041533986201Bruder Livengood9862010729932026-02-25
00041533986300Bruder Livengood9863010729942026-02-25
00041533986508Bruder9865010839302026-02-25
00041533986515Bruder Karpecki9865113014602026-02-25
00041533986539Bruder Karpecki9865313094372026-02-25
00041533986546Bruder Karpecki9865413014632026-02-25
00041533986577Bruder Karpecki9865713014672026-02-25
00041533986584Bruder9865813014612026-02-25
00041533987031Bruder9870313014622026-02-25
00041533987048Bruder 9870413014742026-02-25
00041533987079Bruder9870713014852026-02-25
00041533996538Bruder Karpecki9965310942322026-02-25
00041533986126Bruder 9861213018522025-11-21
00041533986133Bruder9861313014572025-11-21
00041533986553Bruder Karpecki9865513014652025-11-21
00041533987055Bruder9870513014842025-11-21
00041533986102Bruder Collins9861010729922025-10-20

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
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
00810158214194PRINCETONPrinceton Medical Group, Inc.HNW2025-01-27
00757770410668Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770414949Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770419166Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20