FDA.reportPublic FDA data

Epsilon USA

Primary DI
G346EC1460
Brand
Epsilon USA
Company
EPSILON EYE CARE PRIVATE LIMITED
Model
EC-146
Device description
Castroviejo Caliper Straight 20 mm Spread (Overall 85 mm) Stainless Steel
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOECaliper, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOECaliper, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G346EC1460PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic calliperA hand-held manual ophthalmic measuring instrument consisting of two legs hinged at one end and designed to measure the diameter, length, angles, and thicknesses of the eye. Some types, known as a blepharometer, can be used to measure the thickness of the eyelid and the force of the lid closure.

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
00198506089053ELMED INCORPORATEDELMED INCORPORATEDHOE2026-03-03
00852194002090HAI CaliperHightech American Industrial Labs IncHOE2025-12-16
09348811124524INKAThe Trustee for KAISER FAMILY TRUSTHOE2025-11-28
00810207782575Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHOE2025-11-24
00810207782582Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHOE2025-11-24
00194613007409MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007423MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007430MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007454MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007508MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613051952MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613112783MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
04058935011055Castroviejo CaliperBausch & Lomb GmbHHOE2025-07-10
04058935011062Castroviejo Marking CaliperBausch & Lomb GmbHHOE2025-07-10
G412PH94030MR PHACOCrestpoint Management LimitedHOE2025-06-09
G412PH94071T0MR PHACOCrestpoint Management LimitedHOE2025-06-09
G412PH9408T0MR PHACOCrestpoint Management LimitedHOE2025-06-09
G2231113910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOE2025-06-04
G412PH20330MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH61270MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62500MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62510MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62520MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62540MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62550MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62560MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH6433L0MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH6433R0MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH6434L0MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH6434R0MR PHACOCrestpoint Management LimitedHOE2025-05-27