FDA.reportPublic FDA data

Marker, Ocular

Primary DI
00841668104644
Brand
Marker, Ocular
Company
KATENA PRODUCTS, INC.
Model
K3-8135
Catalog number
K3-8135
Device description
BORES O-Z MARKER 4.25MM
Published
2020-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00841668104644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668104644008416681046448416681046440841668104644

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.

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841668145906BLINK60-127360-12732026-03-23
00841668145913BLINK60-128060-12802026-03-23
00841668145920BLINK60-128160-12812026-03-23
00841668145937BLINK60-128460-12842026-03-23
00841668145944BLINK60-128560-12852026-03-23
00841668145951BLINK60-159260-15922026-03-23
00841668145968BLINK60-159960-15992026-03-23
00841668145982BLINK60-161060-16102026-03-23
00841668145999BLINK60-161760-16172026-03-23
00841668146002BLINK60-161860-16182026-03-23
00841668146019BLINK60-163060-16302026-03-23
00841668146040BLINK60-163960-16392026-03-23
00841668146057BLINK60-164260-16422026-03-23
00841668146071BLINK60-500460-50042026-03-23
00841668146088BLINK60-500660-50062026-03-23
00841668146095BLINK60-500860-50082026-03-23
00841668146101BLINK60-500960-50092026-03-23
00841668146118BLINK60-502560-50252026-03-23
00841668146125BLINK60-502660-50262026-03-23
00841668146132BLINK60-503060-50302026-03-23

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
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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