FDA.reportPublic FDA data

Sterile, Single Use, Manipulator Sinskey 1, 1mm Altitude, Tip 0, 2mm, 110mm

Primary DI
05404027421865
Brand
Sterile, Single Use, Manipulator Sinskey 1, 1mm Altitude, Tip 0, 2mm, 110mm
Company
Hasa Optix
Model
654121
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
05404027421865PrimaryGS10
05404027407036Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404027421865054040274218655404027421865
05404027407036054040274070365404027407036

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

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05404027419633Sterile,Single Use,Vitreoretinal Forceps,Gripping Forceps,RoundedTips,25G,145mm6560282024-07-22
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05404027449258Accord Cataract SetHA-SET0602025-02-21
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05404027449289Set Cataracte Ste GenevieveHA-SET0612025-02-21
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