DEVICE: Epsilon USA (G346ECF520)
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Device Identifier (DI) Information
Epsilon USA
ECF-52
In Commercial Distribution
EPSILON EYE CARE PRIVATE LIMITED
ECF-52
In Commercial Distribution
EPSILON EYE CARE PRIVATE LIMITED
Fixation Forceps 0.50 1x2 Teeth with Lock (110 mm overall) Titanium
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 62674 | Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable |
A 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HNR | Forceps, Ophthalmic |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
No
Yes
CLOSE
Yes
| Sterilization Method [?] |
|---|
| Dry Heat Sterilization |
| Moist Heat or Steam Sterilization |
| Ethylene Oxide |
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
18328692-c8e5-4ca9-a94c-ad3495454550
July 04, 2023
2
November 16, 2022
July 04, 2023
2
November 16, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(909) 984-4614
epsilonusa1@gmail.com
epsilonusa1@gmail.com