FDA.reportPublic FDA data

Epsilon USA

Primary DI
G346EA41VSS0
Brand
Epsilon USA
Company
EPSILON EYE CARE PRIVATE LIMITED
Model
EA-41VSS
Device description
Nabeel IOL Holding Forceps Vertical Squeeze Handle 19G Stainless Steel
Published
2026-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
G346EA41VSS0PrimaryHIBCC0

Sterilization Methods#

Method table
Method
Dry Heat Sterilization
Ethylene Oxide
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
917922762
Device count
1
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G346ED1010Epsilon USAED-1012026-10-28
G346EEN01320Epsilon USAEEN-013-22026-10-28
G346EP690Epsilon USAEP-692026-10-28
G346EP1880Epsilon USAEP-1882026-10-22
G346EA32C0Epsilon USAEA-32C2026-10-16
G346EC1734SS0Epsilon USAEC-173-42026-10-01
G346EA41HSS0Epsilon USAEA-41HSS2026-08-14
G346EP400Epsilon USAEP-402026-07-23
G346EP175RSS0Epsilon USAEP-175RSS2026-07-06
G346E12710Epsilon USAE1-2712026-06-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07612717072169FINESSE REFLEXAlcon Laboratories, Inc.HNR2026-10-28
07612717072176FINESSE REFLEXAlcon Laboratories, Inc.HNR2026-10-28
07612717072190FINESSE REFLEXAlcon Laboratories, Inc.HNR2026-10-28
B382SD902769010Surgical DirectSurgical Direct, Inc.HNR2026-10-28
00724995266707Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266714Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266721Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266738Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266745Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266769Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266776Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266783Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995316280V. MuellerSTERIS Deutschland GmbHHNR2026-10-27
00190776437039MillenniumAvalign Technologies, Inc.HNR2026-10-23
00190776437046MillenniumAvalign Technologies, Inc.HNR2026-10-23
00190776437053MillenniumAvalign Technologies, Inc.HNR2026-10-23
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
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