FDA.reportPublic FDA data

Lacrimal Dilator

Primary DI
00841668108666
Brand
Lacrimal Dilator
Company
KATENA PRODUCTS, INC.
Model
K7-2300
Catalog number
K7-2300
Device description
CASTROVIEJO LACRIMAL DILATOR
Published
2020-09-14
Public version status
Update
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
00841668108666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668108666008416681086668416681086660841668108666

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)989-1600info@katena.com
+1(973)989-1600inquiries.corzaeye@corza.com

Regulatory Flags#

DUNS number
085668598
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841668144299KatenaK3-9258K3-92582026-03-31
00841668144305KatenaK3-9259K3-92592026-03-31
00841668144312KatenaK3-9261K3-92612026-03-31
00841668144329KatenaK3-9262K3-92622026-03-31
00841668144336KatenaK3-9263K3-92632026-03-31
00841668144343KatenaK3-9264K3-92642026-03-31
00841668144350KatenaK3-9265K3-92652026-03-31
00841668144367KatenaK3-9266K3-92662026-03-31
00841668144374KatenaK3-9267K3-92672026-03-31
00841668144381KatenaK5-6220K5-62202026-03-31
00841668144398KatenaK3-9268K3-92682026-03-31
00841668144404KatenaK3-9269K3-92692026-03-31
00841668144428KatenaK3-9270K3-92702026-03-31
00841668144435KatenaK3-9274K3-92742026-03-31
00841668144442KatenaK3-9271K3-92712026-03-31
00841668144497BLINK60-127560-12752026-03-26
00841668144619BLINK60-163760-16372026-03-26
00841668144626BLINK60-163860-16382026-03-26
00841668144657BLINK60-500160-50012026-03-26
00841668144855BLINK60-510860-51082026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00757770420681Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770421060Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770425679Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770430680Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
00757770434084Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20
G223M1132390Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNW2024-11-11
G2231132250Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNW2024-10-05
00194613045685MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2024-08-15
00190776385699MillenniumAvalign Technologies, Inc.HNW2024-05-09
00810158212053PRINCETONPrinceton Medical Group, Inc.HNW2024-04-26
00888867462021Arthrex®ARTHREX, INC.HNW2024-03-08
00888867462038Arthrex®ARTHREX, INC.HNW2024-03-08
00888867462045Arthrex®ARTHREX, INC.HNW2024-03-08