FDA.reportPublic FDA data

Ophthalmic Scissors

Primary DI
00841668115398
Brand
Ophthalmic Scissors
Company
KATENA PRODUCTS, INC.
Model
RED-002
Catalog number
RED-002
Device description
TENOTOMY SCISSORS, WESTCOTT-STYLE, BLUNT
Published
2022-11-29
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
HNFSCISSORS, OPHTHALMIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841668115398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668115398008416681153988416681153980841668115398

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
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
00810220800201Adler Instrument CompanyAdler, Inc.HNF2026-05-26
00192896122833Intraocular SetSONTEC INSTRUMENTS, INC.HNF2026-03-19
00198506089602ELMED INCORPORATEDELMED INCORPORATEDHNF2026-03-17
00192896122819Reynolds Tenotomy ScissorsSONTEC INSTRUMENTS, INC.HNF2026-03-10
00840319758366Hayden MedicalHayden Medical, Inc.HNF2025-12-24
00840319758373Hayden MedicalHayden Medical, Inc.HNF2025-12-24
G2231135500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNF2025-12-16
G2231135900Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNF2025-12-16
00852194002045HAI ScissisorsHightech American Industrial Labs IncHNF2025-12-15
04059453156839Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
04059453161697Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
04059453162632Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
00190776415167MillenniumAvalign Technologies, Inc.HNF2025-12-03
09348811004185INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-12-02
04059453117205Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-09-25
04059453119780Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-08-25
00757770406401Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770419197Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770423040Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770417780Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770483563Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770483570Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770486175Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770492350Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770510603Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00194613003784MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613003791MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004101MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004316MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004682MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01