FDA.reportPublic FDA data

I & A Cannula Simcoe Regular 23Gx23G 0.3 mm Port, Curved

Primary DI
08056477558041
Brand
I & A Cannula Simcoe Regular 23Gx23G 0.3 mm Port, Curved
Company
AKTIVE SRL
Model
5086
Catalog number
5086
Device description
I & A Cannula Simcoe Regular 23Gx23G 0.3 mm Port, Curved
Published
2023-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052276012449PrimaryGS10
08056477558041Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052276012449080522760124498052276012449
08056477558041080564775580418056477558041

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA 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 or a basic handle (without controls). 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 single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
433533053
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
08056477557655Phaco Slit Knife 2.4 mm Bevel Up Angled F-24/AF-24/A2024-01-17
08058340226217Phaco Slit Knife 2.4 mm Bevel Up Angled with protectionF-24/AP1F-24/AP12024-01-17
08052276001665Phaco Slit Knife 2.4 mm Dual Bevel Up Angled with protectionF-24/AP2F-24/AP22024-01-17
08056477557662Phaco Slit Knife 2.65 mm Bevel Up Angled F-26/AF-26/A2024-01-17
08058340226224Phaco Slit Knife 2.65 mm Bevel Up Angled with protectionF-26/AP1F-26/AP12024-01-17
08052276015167Phaco Slit Knife 2.65 mm Dual Bevel Angled with protectionF-26/AP2F-26/AP22024-01-17
08056477557679Phaco Slit Knife 2.75 mm Bevel Up AngledF-27/AF-27/A2024-01-17
08058340226248Phaco Slit Knife 2.75 mm Bevel Up Angled with protectionF-27/AP1F-27/AP12024-01-17
08052276015174Phaco Slit Knife 2.75 mm Dual Bevel Angled with protectionF-27/AP2F-27/AP22024-01-17
08056477557686Phaco Slit Knife 2.85 mm Bevel Up Angled F-28/AF-28/A2024-01-17
08058340226279Phaco Slit Knife 2.85 mm Bevel Up Angled with protectionF-28/AP1F-28/AP12024-01-17
08052276015181Phaco Slit Knife 2.8 mm Dual Bevel Angled with protectionF-28/AP2F-28/AP22024-01-17
08056477557693Phaco Slit Knife 3.0 mm Bevel Up AngledF-30/AF-30/A2024-01-17
08058340226286Phaco Slit Knife 3.0 mm Bevel Up Angled with protectionF-30/AP1F-30/AP12024-01-17
08052276015198Phaco Slit Knife 3.0 mm Dual Bevel Angled with protectionF-30/AP2F-30/AP22024-01-17
08056477557709Phaco Slit Knife 3.2 mm Bevel Up Angled F-32/AF-32/A2024-01-17
08058340226293Phaco Slit Knife 3.2 mm Bevel Up Angled with protectionF-32/AP1F-32/AP12024-01-17
08052276015204Phaco Slit Knife 3.2 mm Dual Bevel Angled with protectionF-32/AP2F-32/AP22024-01-17
08052276001689Phaco Slit Knife 3.4 mm Bevel Up Angled with protectionF-34/AP1F-34/AP12024-01-17
08056477557716Scleral Knife Angled G-57/AG-57/A2024-01-17

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00841668146347BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146354BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146361BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146378BLINKKATENA PRODUCTS, INC.HMX2026-03-23