FDA.reportPublic FDA data

Subretinal injection needle 23G tapered to 38G complete with handpiece

Primary DI
08052276026743
Brand
Subretinal injection needle 23G tapered to 38G complete with handpiece
Company
AKTIVE SRL
Model
AK-0468
Catalog number
AK-0468
Device description
Subretinal injection needle 23G tapered to 38G complete with handpiece
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
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052276026743PrimaryGS10
08052276001627Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052276026743080522760267438052276026743
08052276001627080522760016278052276001627

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic working-channel cannula, single-useA sterile rigid tube designed to create a channel through the sclera for internal ocular access during posterior segment ophthalmic surgery. It is typically made of plastic materials or high-grade stainless steel and enables the introduction of ophthalmic surgical instruments; it may also be used for irrigation (i.e., the infusion of fluids to maintain the interior pressure of the eye during 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

Regulatory Flags#

DUNS number
433533053
Device count
6
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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Primary DI, Brand, Company table
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B382S347061000Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S34745150Surgical DirectSurgical Direct, Inc.HMX2026-07-31
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00840285320796Walcott Rx ProductsWalcott Rx Product IncHMX2026-06-26
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