AccessGUDID - DEVICE: Epsilon USA (G346ECF04SS0)

GUDID

Device Identifier (DI) Information

Brand Name: Epsilon USA
Version or Model: ECF-04SS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EPSILON EYE CARE PRIVATE LIMITED

Primary DI Number: G346ECF04SS0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 917922762 *Terms of Use

Device Description: .12 1x2 Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Stainless Steel .20 1x2 Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Stainless Steel .30 1x2 Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Stainless Steel .50 1x2 Teeth Castroviejo Forceps with Tying Platform Forceps (110 mm overall) Stainless Steel

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 60438722-c94d-4a39-8265-11f081024b4f
Public Version Date: February 15, 2023
Public Version Number: 1
DI Record Publish Date: February 07, 2023