Rayner Cataract Set 13

GUDID 05404027446639

Hasa Optix

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID05404027446639
NIH Device Record Key43397236-5989-476c-acbe-1bd5103179ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameRayner Cataract Set 13
Version Model NumberHA-SET013
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 Kittrue
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
Phone+32025246388
Emailinfo@hasaoptix.com

Operating and Storage Conditions

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,
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105404027444611 [Primary]
GS105404027446639 [Unit of Use]

FDA Product Code

PZGSurgical eye tray

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-21
Device Publish Date2023-11-13

Devices Manufactured by Hasa Optix

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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

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