FDA.reportPublic FDA data

Epsilon USA

Primary DI
G346EC1130
Brand
Epsilon USA
Company
EPSILON EYE CARE PRIVATE LIMITED
Model
EC-1-13
Device description
Desmarres Lid Retractor 13 mm Stainless Steel
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNIRetractor, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G346EC1130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periocular/lacrimal retractor, hand-held, reusableA hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
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
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
00190776420765MillenniumAvalign Technologies, Inc.HNI2026-04-30
00190776420840MillenniumAvalign Technologies, Inc.HNI2026-04-30
00190776420512MillenniumAvalign Technologies, Inc.HNI2026-04-16
G22351091I0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNI2026-04-09
00190776418007MillenniumAvalign Technologies, Inc.HNI2026-03-23
00757770668427Bausch + LombBausch & Lomb IncorporatedHNI2026-02-04
00757770708260Bausch + LombBausch & Lomb IncorporatedHNI2026-02-04
00757770652518Bausch + LombBausch & Lomb IncorporatedHNI2025-09-12
00757770668083Bausch + LombBausch & Lomb IncorporatedHNI2025-09-12
G2231109830Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNI2025-08-11
00757770421985Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770423934Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770455720Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770510405Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770437429Bausch + LombBausch & Lomb IncorporatedHNI2025-08-05
00757770668519Bausch + LombBausch & Lomb IncorporatedHNI2025-08-05
00194613005924MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
00194613005948MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
00194613085896MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
00194613104177MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
04058935011826Berke-Jaeger Lid PlateBausch & Lomb GmbHHNI2025-07-11
00850003089355N/AOptalmed, LLCHNI2025-07-07
00850003089362N/AOptalmed, LLCHNI2025-07-07
G346EC1150Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNI2025-06-26
00190776401276MillenniumAvalign Technologies, Inc.HNI2025-06-10
G412H17300MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412H17350MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH62010MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH62020MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH62680MR PHACOCrestpoint Management LimitedHNI2025-06-07