FDA.reportPublic FDA data

Irrigating Cystotome Formed 27G x 16mm

Primary DI
08056477557129
Brand
Irrigating Cystotome Formed 27G x 16mm
Company
AKTIVE SRL
Model
5008
Catalog number
5008
Device description
Irrigating Cystotome Formed 27G x 16mm
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
HNYCystotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNYCystotomeOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052276012937PrimaryGS10
08056477557129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052276012937080522760129378052276012937
08056477557129080564775571298056477557129

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical irrigation/infusion/aspiration handle, single-useA hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. 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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