FDA.reportPublic FDA data

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

Primary DI
05404027406701
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
Rx
false
OTC
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
371290408
Device count
10
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
true
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
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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