FDA.reportPublic FDA data

Epsilon USA

Primary DI
G346ED1010
Brand
Epsilon USA
Company
EPSILON EYE CARE PRIVATE LIMITED
Model
ED-101
Device description
Vannas Scissors Curved Blades 10mm Stainless Steel; Overall 90 mm
Published
2026-10-28
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
HNFScissors, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G346ED1010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic suture scissorsA hand-held ophthalmic surgical instrument used to cut suture during eye surgery. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the fine blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes. This is a reusable device.

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
G346EEN01320Epsilon USAEEN-013-22026-10-28
G346EP690Epsilon USAEP-692026-10-28
G346EP1880Epsilon USAEP-1882026-10-22
G346EA32C0Epsilon USAEA-32C2026-10-16
G346EA41VSS0Epsilon USAEA-41VSS2026-10-14
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
00190776439828MilleniumAvalign Technologies, Inc.HNF2026-10-28
B382SD9039901000Surgical DirectSurgical Direct, Inc.HNF2026-10-28
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00724995315917V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
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00724995315962V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315979V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315986V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315993V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
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00724995316518V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316525V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316570V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316587V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316594V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
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00724995316655V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316693V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316709V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316716V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316723V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316730V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316747V. MuellerSTERIS Deutschland GmbHHNF2026-10-27