FDA.reportPublic FDA data

KOCH ENDOCAPSULAR PUNCH 5.5MM

Primary DI
00841668142844
Brand
KOCH ENDOCAPSULAR PUNCH 5.5MM
Company
KATENA PRODUCTS, INC.
Model
AE-8310
Catalog number
AE-8310
Device description
KOCH ENDOCAPSULAR PUNCH 5.5MM
Published
2022-12-07
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
HNJPunch, corneo-scleral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNJPunch, Corneo-ScleralOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841668142844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668142844008416681428448416681428440841668142844

GMDN Terms#

Term, Definition table
TermDefinition
Corneoscleral punchA hand-held, manual ophthalmic surgical instrument designed to excise a segment of tissue (frequently in the form of a disc) from the sclera or cornea of a patient or from grafts taken from cadaver donors. It typically has a set of sharp, hollow tips at the distal end (a rotary mechanism that may be either integral or an attachment) operated by squeezing a two-part handle. The device is used mainly to perform ophthalmic graft implantations or, less frequently, to obtain grafts from the sclera of cadaver donors. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+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
00757770419807Bausch + LombBausch & Lomb IncorporatedHNJ2026-04-29
00757770500437Bausch + LombBausch & Lomb IncorporatedHNJ2025-08-15
00194613036690MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086510MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086527MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086879MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087005MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087012MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087463MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087555MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613099756MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613100049MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613103453MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108281MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108809MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108816MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108915MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613109646MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613109691MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613109707MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110260MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110307MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110390MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110406MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110857MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110994MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111397MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111908MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111915MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613123604MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01