FDA.reportPublic FDA data

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

Primary DI
05404027424934
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
Rx
false
OTC
false
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

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
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
05404027449234Set Cataracte Clinique BonnefonHA-SET0562025-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G223M1113100Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHLF2025-06-20
G22314012520Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHLF2025-04-16
08175700107228Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107235Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107242Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107259Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107266Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107273Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107297Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107396Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107402Bores Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107419Bores Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700108010Centration MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700108027Centration MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700109628LRI/Toric MarkersAURORA SURGICAL, LLCHLF2024-07-11
08175700109635LRI/Toric MarkersAURORA SURGICAL, LLCHLF2024-07-11
08175700106764MarkerAURORA SURGICAL, LLCHLF2024-07-10
08175700106771MarkerAURORA SURGICAL, LLCHLF2024-07-10
08175700107211Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-10
08175700111607LASIK CannulasAURORA SURGICAL, LLCHLF2024-01-16
05404027410104Sterile,Single Use,Mendez Degree Gauge, form 0To 180,Internal Diameter 12.0mmHasa OptixHLF2023-11-13
08175700107075Hoffer Optical Zone Marker, With Cross Hairs, 4.75mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107099Hoffer Optical Zone Marker, With Cross Hairs, 5.5mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107105Hoffer Optical Zone Marker, With Cross Hairs, 6.0mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107112Hoffer Optical Zone Marker, With Cross Hairs, 6.5mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107136Hoffer Optical Zone Marker, With Cross Hairs, 7.5mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107143Hoffer Optical Zone Marker, With Cross Hairs, 8.0mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107150Hoffer Optical Zone Marker, With Cross Hairs, 8.5mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107167Hoffer Optical Zone Marker, With Cross Hairs, 9.0mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107174Hoffer Optical Zone Marker, With Cross Hairs, 9.5mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23