FDA.reportPublic FDA data

Charles Cannula Standard 27G

Primary DI
08056477552032
Brand
Charles Cannula Standard 27G
Company
AKTIVE SRL
Model
AK-0523
Catalog number
AK-0523
Device description
Charles Cannula Standard 27G
Published
2023-06-16
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
08052276027344PrimaryGS10
08056477552032Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052276027344080522760273448052276027344
08056477552032080564775520328056477552032

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
5
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810163790577Diamatrix Ltd.DiamatrixHMX2026-05-26
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00841668145920BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145937BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145944BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145951BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146040BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146057BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146088BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146101BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146118BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146125BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146156BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146163BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146187BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146217BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146224BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146255BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145487BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146286BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146293BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146309BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146316BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146323BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146330BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146347BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146354BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146361BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146378BLINKKATENA PRODUCTS, INC.HMX2026-03-23