FDA.reportPublic FDA data

Epsilon USA

Primary DI
G346EA40SS0
Brand
Epsilon USA
Company
EPSILON EYE CARE PRIVATE LIMITED
Model
EA-40SS
Device description
Snyder IOL Cutter, angled shaft, straight 4.5mm blades, micro serrated lower blade, blunt tips, squeeze handle 18G Stainless Steel
Published
2025-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNFScissors, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G346EA40SS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic suture scissorsA hand-held ophthalmic surgical instrument used to cut suture during eye surgery. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the fine blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"

Contacts#

Phone, Email table
PhoneEmail
(909)984-4614epsilonusa1@gmail.com

Regulatory Flags#

DUNS number
917922762
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G346EA47SS0Epsilon USAEA-47SS2026-05-12
G346EA0325SS0Epsilon USAEA-03-25SS2026-04-30
G346EA4018GSS0Epsilon USAEA-40SS 18GA2026-04-23
G346EA50LH23GSS0Epsilon USAEA-50-LH-23GSS2026-04-23
G346EA50RH23GSS0Epsilon USAEA-50-RH23G SS2026-04-23
G346EP02SSS0Epsilon USAEP-02SSS2026-04-23
G346ESF105SS0Epsilon USAESF-10-52026-04-23
G346P1607SS0Epsilon USAP-1607 SS2026-04-23
G346EC34Epsilon USAEC-342026-04-20
G346EEN008Epsilon USAEEN-0082026-04-20
G346EP1850Epsilon USAEP-1852026-04-02
G346EP44900Epsilon USAEP-44-902026-04-01
G346EP19A0Epsilon USAEP-19A2026-03-24
G346EEC0330Epsilon USAEEC-0332026-03-18
G346EA0323SS0Epsilon USAEA-03-23 SS2026-03-12
G346EEC2000Epsilon USAEEC-2002026-03-04
G346BP01RSS0Epsilon USABP-01R SS2026-03-02
G34EP223R0Epsilon USAEP-223R2026-02-27
G346ET160Epsilon USAET-162026-02-17
G3446EP219SS0Epsilon USAEP-219SS2026-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04059453161574Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2026-06-03
04251047920554Vannas Capsulotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047921278Metzenbaum ScissorsA1 Medical GmbHHNF2026-05-29
04251047931680Super-Cut Westcott Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047931697Super-Cut Westcott Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047932021Super-Cut Stevens Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047936395Vitrectomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047936432Gerten Iridectomy ScissorA1 Medical GmbHHNF2026-05-29
G346EA4018GSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2026-04-23
G2231349550Ophthalmic ScissorsMedetz Surgical Instruments LLCHNF2026-04-09
09348811004192INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-11-19
09348811004260INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-11-19
G346EA0823GSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2025-09-29
07612717071643FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
07612717071704FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
07612717071735FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
08052276028358Retinal Tip 23G Microscissors CurvedAKTIVE SRLHNF2024-01-15
08052276028372Retinal Tip 25G Microscissors CurvedAKTIVE SRLHNF2024-01-15
08052276028464Retinal Tip vertical 20GAKTIVE SRLHNF2024-01-15
08052276028488Retinal Tip vertical 23GAKTIVE SRLHNF2024-01-15
08052276028501Retinal Tip vertical 25GAKTIVE SRLHNF2024-01-15
0805227602804455° Rotary microscissor 20G only Tip AKTIVE SRLHNF2024-01-11
08052276028129Retinal Tip 20G Microscissors CurvedAKTIVE SRLHNF2024-01-11
08052276028143Retinal Tip 20G Microscissors StraightAKTIVE SRLHNF2024-01-11
08052276028310Retinal Tip 23G Microscissors StraightAKTIVE SRLHNF2024-01-11
08052276028334Retinal Tip 25G Microscissors StraightAKTIVE SRLHNF2024-01-11
08175700144605Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700144612Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700145206Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700145213Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10