FDA.reportPublic FDA data

Mrk, Ocular

Primary DI
00841668120804
Brand
Mrk, Ocular
Company
KATENA PRODUCTS, INC.
Model
08-15128
Catalog number
08-15128
Device description
Hoffer-Optical Zone Marker 11.00mm
Published
2022-11-16
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
HMRMarker, ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841668120804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668120804008416681208048416681208040841668120804

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker, reusableA manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. It is typically made of high-grade stainless steel and includes a long slender handle with a distal end having characteristics for producing specific markings. The device may have a defined pattern of fine marking surfaces (e.g., cross hairs, symmetrical or asymmetrical interlinking wires) that simultaneously engage corneal tissue. Some types are used with a corneal marking pad to transfer ink to the anterior of the eye; other types are used with a slit lamp to precisely incise vertical and horizontal points for precision alignment. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter11Millimeter

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
G346BP01RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-03-02
G346ET160Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-02-17
00642356004709Mastel Surgical Inc.Mastel Surgical Inc.HMR2026-02-11
B382S34556140Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S4901000Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S5616020Surgical DirectSurgical Direct, Inc.HMR2026-02-04
G346ET390Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-01-21
B382S345201000Surgical DirectSurgical Direct, Inc.HMR2025-12-10
B382SD9345561010Surgical DirectSurgical Direct, Inc.HMR2025-09-18
B382SD934557100Surgical DirectSurgical Direct, Inc.HMR2025-09-18
00757770492312Bausch + LombBausch & Lomb IncorporatedHMR2025-08-04
00194613001964MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613002688MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613040093MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613042431MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049249MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049539MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
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00194613049782MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049799MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613049805MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613056834MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613086978MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613086985MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613102463MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613102524MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613102531MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613102647MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01
00194613106256MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01