iAccess

Primary DI
00853704002463
Brand
iAccess
Company
GLAUKOS CORPORATION
Model
AX1
Catalog number
AX1
Device description
Precision Blade
Published
2022-05-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNNKnife, Ophthalmic
HRHTrephine, Manual, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1
HRHTrephine, Manual, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853704002463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853704002463008537040024638537040024630853704002463

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic knife, single-useA sterile, hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ silicon (i.e., a brittle metalloid material) blades. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-367-9600Quality@glaukos.com

Regulatory Flags#

DUNS number
012835406
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853704002456iPRIMEVCP100VCP1002022-05-13
00853704002487iStent inject W Trabecular Micro-Bypass System with Infinite Injector TechnologyiS2iS22025-04-30
00853704002449iStent InfiniteiS3iS3-US2022-10-19
00853704002470iStent infiniteiS3iS32022-10-05
00853704002319iStent inject WG2-WG2-W2020-08-11
00853704002005iStentGTS100RGTS100R2015-09-21
00853704002012iStentGTS100LGTS100L2015-09-21
00853704002029iStentGTS100iGTS100i2015-09-21
00853704002203iStent injectG2-M-ISG2-M-IS2018-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251047902956Kelly Descemet Membrane PunchA1 Medical GmbHHNN2026-05-29
G412PH62100MR PHACOCrestpoint Management LimitedHRH2025-05-27
G412PH62110MR PHACOCrestpoint Management LimitedHRH2025-05-27
G412PH62170MR PHACOCrestpoint Management LimitedHRH2025-05-27
G412PH62180MR PHACOCrestpoint Management LimitedHRH2025-05-27
G412PH62190MR PHACOCrestpoint Management LimitedHRH2025-05-27
G412PH62200MR PHACOCrestpoint Management LimitedHRH2025-05-27
G412PH62210MR PHACOCrestpoint Management LimitedHRH2025-05-27
G412PH62220MR PHACOCrestpoint Management LimitedHRH2025-05-27
G412PH62230MR PHACOCrestpoint Management LimitedHRH2025-05-27
G412PH62240MR PHACOCrestpoint Management LimitedHRH2025-05-27
G412PH62250MR PHACOCrestpoint Management LimitedHRH2025-05-27
08052276033635Phaco Slit Knife 2.4 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033642Phaco Slit Knife 2.4 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033659Phaco Slit Knife 2.4 mm Dual Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033666Phaco Slit Knife 2.65 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033673Phaco Slit Knife 2.65 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033680Phaco Slit Knife 2.65 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033697Phaco Slit Knife 2.75 mm Bevel Up AngledAKTIVE SRLHNN2024-01-17
08052276033703Phaco Slit Knife 2.75 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033710Phaco Slit Knife 2.75 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033727Phaco Slit Knife 2.85 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033734Phaco Slit Knife 2.85 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033741Phaco Slit Knife 2.8 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033758Phaco Slit Knife 3.0 mm Bevel Up AngledAKTIVE SRLHNN2024-01-17
08052276033765Phaco Slit Knife 3.0 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033772Phaco Slit Knife 3.0 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033789Phaco Slit Knife 3.2 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033796Phaco Slit Knife 3.2 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033802Phaco Slit Knife 3.2 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17