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

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusableA hand-held manual surgical instrument designed to facilitate the grasping, manipulation, or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design with variously designed tips, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. This is a reusable device intended to be sterilized prior to use.

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00724995318307V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318338V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318345V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318451V. MuellerSTERIS Deutschland GmbHHNR2026-09-25