FDA.reportPublic FDA data

Sterile,Single Use,Mendez Degree Gauge, form 0To 180,Internal Diameter 12.0mm

Primary DI
05404027410104
Brand
Sterile,Single Use,Mendez Degree Gauge, form 0To 180,Internal Diameter 12.0mm
Company
Hasa Optix
Model
558002
Published
2023-11-13
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
HLFDevice, measuring, lens radius, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLFDevice, Measuring, Lens Radius, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05404027410104PrimaryGS10
05404027424934Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404027410104054040274101045404027410104
05404027424934054040274249345404027424934

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic angular gauge, single-useA non-powered, hand-held, ophthalmic surgical device designed to measure angular distances radially around the surface of the eye [e.g., during intraocular lens (IOL) implantation/alignment]. Also referred to as a Mendez degree gauge, it consists of a handle with a distal ring which includes angle degree markings; it may include blunt teeth on the underside of the ring to allow it to grip to the eye during use. It is not intended for use as a marker. 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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Primary DI, Brand, Model table
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05404027449388Sub Tenon Set RaynerHA-SET0652025-06-12
15404027449385Sub Tenon Set RaynerHA-SET0652025-06-12
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05404027417042Sterile, Single Use, ICL Forceps, 20G6510722023-11-23
05404027419572Sterile, Single Use, Vitreoretinal Forceps, Asymmetric End-Gripping, 25G, 145mm5560422024-07-22
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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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