FDA.reportPublic FDA data

Susol® Needle Holder Kilner

Primary DI
05060418836887
Brand
Susol® Needle Holder Kilner
Company
BAILEY INSTRUMENTS LTD
Model
SS18-1716-F
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060418836870PackageGS110In Commercial Distribution
05060418836887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060418836870050604188368705060418836870
05060418836887050604188368875060418836887

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.

Regulatory Flags#

DUNS number
769260357
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
05060418834661Susol® Henckel Tilley Punch Forceps 4.5mmSS42-32152024-05-14
05060418833343Susol® Henckel Tilley Punch Forceps 4.5mmSS42-32152024-05-14
05060418833695Susol® Diamond Bur Pear 2S-DB182024-02-27
05060418833725Susol® Diamond Bur Pear 1S-DB42024-02-27
05060418833732Susol® Diamond Bur 15CS-DB72024-02-27
05060418833749Susol® Diamond Bur 1HP EnucleatorS-DB82024-02-27
05060418833992Susol® Blacks File SE Standard 14cmSS08-05522024-02-27
05060418834012Susol® Probe Flat Head Swan Neck 12.5cmSS08-05562024-02-27
05060418834029Susol® Blacks File Double Ended Micro with Round Probe 14cmSS08-05572024-02-27
05060418833671Susol® Emery Board 18cmCH1452024-02-27
05060418832377Susol® Diamond Bur Pear 2S-DB182024-02-27
05060418832407Susol® Diamond Bur Pear 1S-DB42024-02-27
05060418832414Susol® Diamond Bur 15CS-DB72024-02-27
05060418832421Susol® Diamond Bur 1HP EnucleatorS-DB82024-02-27
05060418832674Susol® Blacks File SE Standard 14cmSS08-05522024-02-27
05060418832698Susol® Probe Flat Head Swan Neck 12.5cmSS08-05562024-02-27
05060418832704Susol® Blacks File Double Ended Micro with Round Probe 14cmSS08-05572024-02-27
05060418836177Susol® Micro Curette Double Ended with holeSS62-43002024-02-27
05060418834883 Susol® Nail Care SetBSDP-022024-02-20
05060418833640 Susol® Nail Care SetBSDP-022024-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421946MillenniumAvalign Technologies, Inc.GEN2026-07-23
00190776403881MillenniumAvalign Technologies, Inc.GEN2026-07-22
00190776403980MillenniumAvalign Technologies, Inc.GEN2026-07-22
00198506092138ELMED INCORPORATEDELMED INCORPORATEDGEN2026-07-22
00840183532093BR Surgical, LLCBR Surgical, LLCGEN2026-07-22
00190776400514MillenniumAvalign Technologies, Inc.GEN2026-07-21
00190776403355MillenniumAvalign Technologies, Inc.GEN2026-07-21
00190776403379MillenniumAvalign Technologies, Inc.GEN2026-07-21
00840183531423BR Surgical, LLCBR Surgical, LLCGEN2026-07-20
00190776402112MillenniumAvalign Technologies, Inc.GEN2026-07-19
00190776402136MillenniumAvalign Technologies, Inc.GEN2026-07-19
00190776400255MillenniumAvalign Technologies, Inc.GEN2026-07-17
B382SD9013461020Surgical DirectSurgical Direct, Inc.GEN2026-07-17
00190776397050MillenniumAvalign Technologies, Inc.GEN2026-07-16
00190776398651MillenniumAvalign Technologies, Inc.GEN2026-07-16
B382SD914264010Surgical DirectSurgical Direct, Inc.GEN2026-07-13
00850083275075Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275082Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275099Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275105Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275112Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275129Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275136Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275143Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275280Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275310Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275334Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275358Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275440Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275471Intrace USAPILOTIS TECH LLCGEN2026-07-03