FDA.reportPublic FDA data

Sterile,Single Use,Kelman-Mcpherson LensForceps,Angled Shafts,Flat Handle,105mm

Primary DI
05404027402178
Brand
Sterile,Single Use,Kelman-Mcpherson LensForceps,Angled Shafts,Flat Handle,105mm
Company
Hasa Optix
Model
551199
Published
2024-07-22
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
HNRForceps, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05404027417004PrimaryGS10
05404027402178Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404027417004054040274170045404027417004
05404027402178054040274021785404027402178

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular lens folderA hand-held, sterile, device designed to uniformly fold a foldable intraocular lens (IOL) in order to reduce its natural physical size so that the IOL can be removed from the IOL folder with an implantation forceps and be implanted into the anterior or posterior chamber of the eye through a small incision during ophthalmic surgery. It is typically made of synthetic material (e.g., polypropylene) and is designed to accept the IOL in its natural unfolded state, when in place the operator activates the folding mechanism. 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
05404027449708Accord SetHA-SET1182026-07-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435721MillenniumAvalign Technologies, Inc.HNR2026-10-21
00190776435318MillenniumAvalign Technologies, Inc.HNR2026-10-19
G346EA32C0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-10-16
00190776434885MillenniumAvalign Technologies, Inc.HNR2026-10-14
00190776434984MillenniumAvalign Technologies, Inc.HNR2026-10-14
00192896123939Bishop Harmon Tissue ForcepsSONTEC INSTRUMENTS, INC.HNR2026-10-14
G346EA41VSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-10-14
00757770602506Bausch + LombBausch & Lomb IncorporatedHNR2026-10-09
00190776436209MillenniumAvalign Technologies, Inc.HNR2026-10-08
00190776433734MillenniumAvalign Technologies, Inc.HNR2026-10-07
00190776436155MillenniumAvalign Technologies, Inc.HNR2026-10-07
0081748902541323ga DEX™ Morris ILM ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620260127ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620360823ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620361525ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620509125ga DEX Stiff NanoTapered Awh ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620510725ga DEX Stiff Morris Honey Badger ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620511425ga DEX Stiff Asymmetrical Tano ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620512125ga (0.50mm) Dex™ Stiff Serrated Jaw ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620513825ga DEX Stiff Maculorhexis ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620514525ga DEX Stiff End Grasper ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620515225ga DEX Stiff Morris ILM ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620516925ga DEX™ Stiff Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
G223M111991S0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-10-01
00190776432942MillenniumAvalign Technologies, Inc.HNR2026-09-30
00724995317973V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318024V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318246V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318253V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318284V. MuellerSTERIS Deutschland GmbHHNR2026-09-25