Sterile,Single Use,Adjustable Speculum,Speculum,14mm Round Solid Blades,L 65mm

GUDID 05404027412610

Hasa Optix

Eyelid speculum, single-use
Primary Device ID05404027412610
NIH Device Record Key95cf719c-b6ff-41a4-88d3-e75a064ca690
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile,Single Use,Adjustable Speculum,Speculum,14mm Round Solid Blades,L 65mm
Version Model Number555028
Company DUNS371290408
Company NameHasa Optix
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com
Phone+32025246388
Emailinfo@hasaoptix.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry; Keep away form the sunlight, storage temperature 0-40°C,

Device Identifiers

Device Issuing AgencyDevice ID
GS105404027412610 [Unit of Use]
GS105404027427447 [Primary]

FDA Product Code

HNCSpecula, ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-30
Device Publish Date2024-07-22

Devices Manufactured by Hasa Optix

05404027449265 - Accord Cataract Set2025-03-03
05404027449289 - Set Cataracte Ste Genevieve2025-03-03
15404027449002 - Set Cataracte CH Prive du Montgarde2024-09-19
05404027400242 - Sterile,SingleUse,CapsulorhexisForceps,CurvedShafts,FlatHandle,Incsion1.8-3.2mm2024-07-30
05404027400303 - Sterile,SingleUse,CapsulorhexisForceps,AngledShaft,RoundHandle,Incsion1.8-3.2mm2024-07-30
05404027400334 - Sterile,SingleUse,CapsulorhexisForceps,AngledShaft,FlatHandle,Incsion1.8-3.2mm2024-07-30
05404027400617 - Sterile,Single Use,ToothedForceps,Straight Shafts,Round KnurledHandle,1X2Teeth2024-07-30
05404027401881 - Sterile, Single Use, Tying Forceps, Straight Shafts, Flat Handle, 105mm2024-07-30

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.