Iris Retractor

Primary DI: 00841668103708
Brand: Iris Retractor
Company: KATENA PRODUCTS, INC.
Model: K3-4920
Catalog number: K3-4920
Device description: GRAETHER IRIS RETRACTOR W/ IRRIGATOR STR
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

Related Records

Contact Domains

Product Codes

Code	Name
HOC	Clip, iris retractor

Product Code Classifications

Code	Device	Specialty	Class
HOC	Clip, Iris Retractor	Ophthalmic	1

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
00841668103708	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00841668103708	00841668103708	841668103708	0841668103708

GMDN Terms

Term	Definition
Ocular hook/spatula/manipulator, reusable	A hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a reusable device intended to be sterilized prior to use.

Term

Definition

Ocular hook/spatula/manipulator, reusable

A hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method

Contacts

Phone	Email
+1(973)989-1600	info@katena.com
+1(973)989-1600	inquiries.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

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