FDA.reportPublic FDA data

Iris Forceps

Primary DI
G165SU240900100
Brand
Iris Forceps
Company
ELMED INSTRUMENTS(PVT)LTD.
Model
SU-24-0900-10
Catalog number
SU-24-0900-10
Device description
Intended Use: Iris Forceps are incredible eye instruments widely used for ophthalmic proceduresPackaging: Packaging: Packaging shall be as per customer requirements e.g set of 25 or set of 50.
Published
2022-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G165SU240900100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, tweezers-like, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
645680588
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G165SU100095240SPONGE FORCEPSSU-10-0095-24SU-10-0095-242022-09-08
G165SU210296250Schroeder ForcepsSU-21-0296-25SU-21-0296-252022-09-08
G165SU70275140Metzenbaum ScissorsSU-7-0275-14SU-7-0275-142022-09-09
G165SU70333180Metzenbaum ScissorsSU-7-0333-18SU-7-0333-182022-09-09
G165SU70149110Operating ScissorsSU-7-0149-11SU-7-0149-112022-09-08
G165SU70149140Operating ScissorsSU-7-0149-14SU-7-0149-142022-09-08
G165SU70153110Operating ScissorsSU-7-0153-11SU-7-0153-112022-09-08
G165SU70153140Operating ScissorsSU-7-0153-14SU-7-0153-142022-09-08
G165SU70242140Mayo ScissorsSU-7-0242-14SU-7-0242-142022-09-08
G165SU70242230Mayo ScissorsSU-7-0242-23SU-7-0242-232022-09-08
G165SU71055110Iris ScissorSU-7-1055-11SU-7-1055-112022-09-08
G165SU71056110Iris ScissorSU-7-1056-11SU-7-1056-112022-09-08
G165SU71105110Strabismus ScissorsSU-7-1105-11SU-7-1105-112022-09-08
G165SU71151140Spencer Stitch ScissorsSU-7-1151-14SU-7-1151-142022-09-08
G165SU71220110Lister Bandage ScissorsSU-7-1220-11SU-7-1220-112022-09-08
G165SU71220140Lister Bandage ScissorsSU-7-1220-14SU-7-1220-142022-09-08
G165SU130176130Halsey Needle HolderSU-13-0176-13SU-13-0176-132022-09-09
G165SU130180130Webster Needle HolderSU-13-0180-13SU-13-0180-132022-09-09
G165SU130184120Derf Needle HolderSU-13-0184-12SU-13-0184-122022-09-09
G165SU130196140Baumgartner Needle HolderSU-13-0196-14SU-13-0196-142022-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088713183PRINCETONPrinceton Medical Group, Inc.HTD2026-07-23
B382SD9017971040Surgical DirectSurgical Direct, Inc.HTD2026-07-23
B382SD9029931060Surgical DirectSurgical Direct, Inc.HTD2026-07-23
00190776400460MillenniumAvalign Technologies, Inc.HTD2026-07-21
00190776395360MillenniumAvalign Technologies, Inc.HTD2026-07-14
B382SD906201100Surgical DirectSurgical Direct, Inc.HTD2026-07-14
B382SD906202100NC0Surgical DirectSurgical Direct, Inc.HTD2026-07-14
B382SD91705515T0Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD91705525T0Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9183761030Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9184571000Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9184932000Surgical DirectSurgical Direct, Inc.HTD2026-07-13
00810158219960PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00810158219977PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00810158219991PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00850088713008PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00850083275174Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275181Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275198Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275204Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275211Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275228Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275518Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275730Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275747Intrace USAPILOTIS TECH LLCHTD2026-07-03
00190776421786MillenniumAvalign Technologies, Inc.HTD2026-06-24
00192896123502Stefan Bone Holding ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123519Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123526Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123533Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24