FDA.reportPublic FDA data

FJ Clip Neo 5

Primary DI
00883475954753
Brand
FJ Clip Neo 5
Company
CHARMANT INC.
Model
24-0003
Published
2023-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GDOApplier, Surgical, Clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883475954753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883475954753008834759547538834759547530883475954753

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip applierA device intended to be used in combination with a compatible flexible endoscope for the application of a gastrointestinal endoscopic clip(s) [not included] to the mucosal lining of the gastrointestinal (GI) tract for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects during an endoscopic procedure. It typically consists of an insertion sheath, a mechanism at the distal end for applying the clips, and a control handle at the proximal end for firing the clips into the target tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
693742728
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883475708523Multi Purpose Forceps37-00352023-09-18
00883475953930Paddle tip Manipulator37-00802023-09-18
00883475953947Ball tip Manipulator37-00812023-09-18
00883475953299MS Round-Crescent-Flat22-01BNJP2024-08-01
00883475953305MS Round-Crescent-Flat22-01BNKP2024-08-01
00883475953312MS Round-ST-Flat22-02BNIP2024-08-01
00883475953329MS Round-ST-Flat22-02BNKP2024-08-01
00883475953411MS Round-ST-CV22-03BNIP2024-08-01
00883475953428MS Round-ST-CV22-03BNKP2024-08-01
00883475951370Pressure Adjustable Micro-Sucker 7S31-50572023-09-18
00883475651300IOL Hook37-00022023-09-18
00883475651324Capsulorrhexis Forceps37-00042023-09-18
00883475651331Micro Scissors(Acute tips)37-00052023-09-18
00883475651348Micro Scissors(Blunt tips)37-00062023-09-18
00883475651355Iris Forceps37-00072023-09-18
00883475651362Needle Holder37-00082023-09-18
00883475651379Wire Speculum37-00092023-09-18
00883475651386Wire Speculum with Blade37-00102023-09-18
00883475679038Micro Forceps CROSS MAX37-00112023-09-18
00883475679045Cilia Forceps CROSS MAX37-00122023-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800042700065Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700904Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700911Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700928Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701369Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701376Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701390Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701406Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702878Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702885Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702892Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702908Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702915Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702922Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08809756910081Artisential Clip Applier LargeLIVSMEDGDO2026-04-21
08809756910104Artisential Clip Applier LargeLIVSMEDGDO2026-04-21
10381780540595CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2026-04-15
10381780540601CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2026-04-15
G58690311220Novo SurgicalNOVO SURGICAL, INC.GDO2025-03-25
10381780544302CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2024-10-02
14026704738110WECKTELEFLEX INCORPORATEDGDO2024-07-17
14026704726384WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726391WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726407WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726414WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726421WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726438WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726445WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726452WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726469WECKTELEFLEX INCORPORATEDGDO2024-03-13