FDA.report

Epsilon USA

Primary DI
G346ESF29CSS0
Brand
Epsilon USA
Company
EPSILON EYE CARE PRIVATE LIMITED
Model
ESF-29CSS
Device description
Utrata Forceps Curved With Platform (85 mm overall) Stainless Steel
Published
2023-02-07
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
G346ESF29CSS0PrimaryHIBCC0

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

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

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G346EP55L0Epsilon USAEP-55L2025-09-26
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G346EC222SS0Epsilon USAEC-222 SS2025-09-18
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G34EP223L0Epsilon USAEP-223L2025-08-13
G346EA01L212521GSS0Epsilon USAEA-01L25-21GSS2025-08-08
G346EC208Epsilon USAEC-2082025-07-07
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04251047911552Faulkner Lens Holding ForcepsA1 Medical GmbHHNR2026-05-22
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04251047917905McPherson Needle HolderA1 Medical GmbHHNR2026-05-22
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04251047919336Jakobi Needle HolderA1 Medical GmbHHNR2026-05-22
04251047925252Ergo Grip Tennant Tying ForcepsA1 Medical GmbHHNR2026-05-22
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04251047925658Ergo Grip Barraquer Needle HolderA1 Medical GmbHHNR2026-05-22
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04251047933172SIGNUM GIANETTI MICS ForcepsA1 Medical GmbHHNR2026-05-22
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