FDA.reportPublic FDA data

SPONGE FORCEPS

Primary DI
G165SU100095240
Brand
SPONGE FORCEPS
Company
ELMED INSTRUMENTS(PVT)LTD.
Model
SU-10-0095-24
Catalog number
SU-10-0095-24
Device description
Intended Use: To hold gauze squares that will absorb excess fluids and blood.Packaging: Packaging shall be as per customer requirements e.g set of 25 or set of 50.
Published
2022-09-08
Public version status
Update
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
G165SU100095240PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, scissors-like, single-useA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. 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
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
G165SU130206130Mayo-Hegar Needle HolderSU-13-0206-13SU-13-0206-132022-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD90120123T0Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD9012101000Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD901229040Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD9012941000Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD901294100T0Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD9012981000Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD901345140Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD901365200Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD9015171000Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD9015171010Surgical DirectSurgical Direct, Inc.HTD2026-10-22
B382SD90190030Surgical DirectSurgical Direct, Inc.HTD2026-10-22
00190776435776MillenniumAvalign Technologies, Inc.HTD2026-10-21
00190776435783MillenniumAvalign Technologies, Inc.HTD2026-10-21
B382SD915758300Surgical DirectSurgical Direct, Inc.HTD2026-10-20
00190776435356MillenniumAvalign Technologies, Inc.HTD2026-10-19
00190776435158MillenniumAvalign Technologies, Inc.HTD2026-10-16
00192896123878Allis Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123885Allis Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123892Ceramitec Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123908Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123915Ceramitec Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00190776434717MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434748MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434755MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434243MillenniumAvalign Technologies, Inc.HTD2026-10-09
00190776436490MilleniumAvalign Technologies, Inc.HTD2026-10-08
B382SD9071922050Surgical DirectSurgical Direct, Inc.HTD2026-10-08
B382SD918660100Surgical DirectSurgical Direct, Inc.HTD2026-10-08
B382SD9013551000Surgical DirectSurgical Direct, Inc.HTD2026-10-07
B382SD9013551010Surgical DirectSurgical Direct, Inc.HTD2026-10-07