FDA.reportPublic FDA data

Sterile, Single Use, Lasik Flap Lifter/Elevator Binder, 120mm

Primary DI
05404027421537
Brand
Sterile, Single Use, Lasik Flap Lifter/Elevator Binder, 120mm
Company
Hasa Optix
Model
554504
Published
2024-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
05404027421537PrimaryGS10
05404027406701Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404027421537054040274215375404027421537
05404027406701054040274067015404027406701

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic curette, single-useA hand-held, manual, ophthalmic surgical instrument typically with a fenestrated, spoon-shaped or ring-like tip which can be either sharp or blunt, intended to be used to obtain or remove eye tissue through a scraping action. It is typically made of metal. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+32025246388info@hasaoptix.com

Regulatory Flags#

DUNS number
371290408
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05404027449708Accord SetHA-SET1182026-07-16
05404027410678Sterile, Single Use, IOL Cutting Scissors 19G6530592025-11-05
05404027449517The Doctor Clinic SetHA-SET0782025-09-12
05404027449524The Doctor Clinic SetHA-SET0782025-09-12
05404027449463Cataract Set Rayner 73-Greens ChopperHA-SET0732025-07-22
05404027449470NHS Scotland Cataract Set Rayner 74HA-SET0742025-07-22
15404027449460Cataract Set Rayner 73-Greens ChopperHA-SET0732025-07-22
15404027449477NHS Scotland Cataract Set Rayner 74HA-SET0742025-07-22
05404027449388Sub Tenon Set RaynerHA-SET0652025-06-12
15404027449385Sub Tenon Set RaynerHA-SET0652025-06-12
05404027404608Sterile,Single Use,Vitreoretinal Forceps,Short End-Gripping Forceps (ilm),23G5560262023-11-13
05404027417042Sterile, Single Use, ICL Forceps, 20G6510722023-11-23
05404027419572Sterile, Single Use, Vitreoretinal Forceps, Asymmetric End-Gripping, 25G, 145mm5560422024-07-22
05404027419626Sterile,Single Use,Vitreoretinal Forceps,Short End-Gripping Forceps, 25G, 145mm6560262024-07-22
05404027419633Sterile,Single Use,Vitreoretinal Forceps,Gripping Forceps,RoundedTips,25G,145mm6560282024-07-22
05404027419695Sterile,Single Use,Vitreoretinal Forceps,Short End-Gripping Forceps, 25G,145mm6560392024-07-22
05404027449258Accord Cataract SetHA-SET0602025-02-21
05404027449272Set Cataracte Ste GenevieveHA-SET0612025-02-21
05404027449265Accord Cataract SetHA-SET0602025-02-21
05404027449289Set Cataracte Ste GenevieveHA-SET0612025-02-21

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