AccessGUDID - DEVICE: Iris Forceps (G165SU240900100)

GUDID

Device Identifier (DI) Information

Brand Name: Iris Forceps
Version or Model: SU-24-0900-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SU-24-0900-10
Company Name: ELMED INSTRUMENTS(PVT)LTD.

Primary DI Number: G165SU240900100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645680588 *Terms of Use

Device Description: Intended Use: Iris Forceps are incredible eye instruments widely used for ophthalmic procedures Packaging: Packaging: Packaging shall be as per customer requirements e.g set of 25 or set of 50.

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:	Yes
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?
62673	Ophthalmic soft-tissue manipulation forceps, tweezers-like, single-use	A sterile, hand-held manual surgical instrument designed to facilitate 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 at the working end, 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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTD	Forceps

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: a4d4b828-9958-4ca4-83c2-13b9aaf385e4
Public Version Date: September 16, 2022
Public Version Number: 1
DI Record Publish Date: September 08, 2022