FDA.report

Epsilon USA

Primary DI
G346ERF28B0
Brand
Epsilon USA
Company
EPSILON EYE CARE PRIVATE LIMITED
Model
ERF-28B
Device description
Capsulorhexis Cross-Action Sub 2.2 Forceps MICS Blunt Tips (106 mm overall) Titanium
Published
2022-11-21
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

Related Records

Product Codes

CodeName
HNRForceps, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G346ERF28B0PrimaryHIBCC0

GMDN Terms

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
Dry Heat Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide

Contacts

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
false
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 DIBrandModelCatalogPublished
G346EP19A0Epsilon USAEP-19A2026-03-24
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
G346ET390Epsilon USAET-392026-01-21
G346EL180Epsilon USAEL-182026-01-19
G346EEN0132Epsilon USAEEN-013-22025-12-17
G346ERF12C0Epsilon USAERF-12C2025-11-24
G346ESF03SS0Epsilon USAESF-03SS2025-11-13
G346EP55L0Epsilon USAEP-55L2025-09-26
G346EP1650Epsilon USAEP-1652025-09-23
G346EC222SS0Epsilon USAEC-222 SS2025-09-18
G346EP98SS0Epsilon USAEP-98SS2025-09-03
G34EP223L0Epsilon USAEP-223L2025-08-13
G346EA01L212521GSS0Epsilon USAEA-01L25-21GSS2025-08-08
G346EC208Epsilon USAEC-2082025-07-07
G346ECF54SS0Epsilon USAECF-54SS2025-07-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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00840319758854Hayden MedicalHayden Medical, Inc.HNR2026-03-06
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