FDA.reportPublic FDA data

Halsey Needle Holder

Primary DI
G165SU130176130
Brand
Halsey Needle Holder
Company
ELMED INSTRUMENTS(PVT)LTD.
Model
SU-13-0176-13
Catalog number
SU-13-0176-13
Device description
Intended Use: Halsey needle holders are finger ring forceps that assist surgeons in guiding and inserting suture needles.Packaging: Packaging shall be as per customer requirements e.g set of 26 or set of 50.
Published
2022-09-09
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
FHQHolder, Needle, Gastroenterologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G165SU130176130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, single-useA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. 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
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
00724995279622V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286248V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286286V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320164V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320263V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320317V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320324V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320331V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320348V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00840319759424Hayden MedicalHayden Medical, Inc.FHQ2026-09-04
00190776419684MillenniumAvalign Technologies, Inc.FHQ2026-08-25
00850083997007Suture SheildSUTURE SHIELD, INC.FHQ2026-08-03
B382SD45267180Surgical DirectSurgical Direct, Inc.FHQ2026-08-03
B382SD90557818E0Surgical DirectSurgical Direct, Inc.FHQ2026-07-29
00810143905076SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905083SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905106SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143907193SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908671SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908701SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909081SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909753SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909760SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212931517SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212931678SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934709SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934716SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934723SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934921SURGIPROSSurgipros, LLCFHQ2026-07-28
00810212934938SURGIPROSSurgipros, LLCFHQ2026-07-28