FDA.reportPublic FDA data

Retinal Scraper 20G Full Handle

Primary DI
08052276027085
Brand
Retinal Scraper 20G Full Handle
Company
AKTIVE SRL
Model
AK-0509/S
Catalog number
AK-0509/S
Device description
Retinal Scraper 20G Full Handle
Published
2024-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HNDSpatula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052276027085PrimaryGS10
08056477559475Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052276027085080522760270858052276027085
08056477559475080564775594758056477559475

GMDN Terms#

Term, Definition table
TermDefinition
Epiretinal/inner limiting membrane scraper, single-useA hand-held manual surgical instrument intended to be used during posterior segment surgery to lift the inner limiting membrane (ILM) and/or an epiretinal membrane (ERM), and which may have additional posterior segment membrane manipulation uses. It includes a dedicated textured tip (e.g., diamond-dusted polymer) intended to effectively grip/lift the membrane for further manipulation (e.g., with forceps); it may additionally include non-powered features (e.g., fibreoptics) to allow cold light to be directed to the surgical site. 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

Regulatory Flags#

DUNS number
433533053
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052276027290Dual Bore Cannula 23G, 36mmAK-0519/XLAK-0519/XL2025-06-04
00805227602729Dual Bore Cannula 23G, 36mmAK-0519/XLAK-0519/XL2023-12-19
08052276029638Eye Shield AK-2000AK-20002024-01-15
08052276033635Phaco Slit Knife 2.4 mm Bevel Up Angled F-24/AF-24/A2024-01-17
08052276033642Phaco Slit Knife 2.4 mm Bevel Up Angled with protectionF-24/AP1F-24/AP12024-01-17
08052276033659Phaco Slit Knife 2.4 mm Dual Bevel Up Angled with protectionF-24/AP2F-24/AP22024-01-17
08052276033666Phaco Slit Knife 2.65 mm Bevel Up Angled F-26/AF-26/A2024-01-17
08052276033673Phaco Slit Knife 2.65 mm Bevel Up Angled with protectionF-26/AP1F-26/AP12024-01-17
08052276033680Phaco Slit Knife 2.65 mm Dual Bevel Angled with protectionF-26/AP2F-26/AP22024-01-17
08052276033697Phaco Slit Knife 2.75 mm Bevel Up AngledF-27/AF-27/A2024-01-17
08052276033703Phaco Slit Knife 2.75 mm Bevel Up Angled with protectionF-27/AP1F-27/AP12024-01-17
08052276033710Phaco Slit Knife 2.75 mm Dual Bevel Angled with protectionF-27/AP2F-27/AP22024-01-17
08052276033727Phaco Slit Knife 2.85 mm Bevel Up Angled F-28/AF-28/A2024-01-17
08052276033734Phaco Slit Knife 2.85 mm Bevel Up Angled with protectionF-28/AP1F-28/AP12024-01-17
08052276033741Phaco Slit Knife 2.8 mm Dual Bevel Angled with protectionF-28/AP2F-28/AP22024-01-17
08052276033758Phaco Slit Knife 3.0 mm Bevel Up AngledF-30/AF-30/A2024-01-17
08052276033765Phaco Slit Knife 3.0 mm Bevel Up Angled with protectionF-30/AP1F-30/AP12024-01-17
08052276033772Phaco Slit Knife 3.0 mm Dual Bevel Angled with protectionF-30/AP2F-30/AP22024-01-17
08052276033789Phaco Slit Knife 3.2 mm Bevel Up Angled F-32/AF-32/A2024-01-17
08052276033796Phaco Slit Knife 3.2 mm Bevel Up Angled with protectionF-32/AP1F-32/AP12024-01-17

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