FDA.reportPublic FDA data

DOUBLE EDGE CYSTOTOME 22 GAUGE 33MM

Primary DI
00841668138533
Brand
DOUBLE EDGE CYSTOTOME 22 GAUGE 33MM
Company
KATENA PRODUCTS, INC.
Model
AE-7130
Catalog number
AE-7130
Device description
DOUBLE EDGE CYSTOTOME 22 GAUGE 33MM
Published
2022-12-07
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
HNYCystotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNYCystotomeOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841668138533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668138533008416681385338416681385330841668138533

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing. It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge22Gauge

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
00841668145968BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668145982BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668145999BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146002BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146019BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146071BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146095BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146132BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146149BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146170BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146194BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146200BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146231BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146248BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00757770416783Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00757770429943Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00757770433896Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00194613002251MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
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00194613002336MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002343MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613002459MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613052317MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613103576MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613103620MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613103859MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613104245MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
00194613104672MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01