FDA.reportPublic FDA data

LANDANGER

Primary DI
03661219198956
Brand
LANDANGER
Company
LANDANGER
Model
B554030
Published
2022-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661219198956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661219198956036612191989563661219198956

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. 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 reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
299889175
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661219357063DELACROIX-CHEVALIERE2290062026-07-23
03661219357070DELACROIX-CHEVALIERE2290112026-07-23
03661219357087DELACROIX-CHEVALIERE2290132026-07-23
03661219357094DELACROIX-CHEVALIERE2290152026-07-23
03661219436348LANDANGERJ01465-232026-07-12
03661219510970LANDANGERDC80308-302026-07-12
03661219512660DELACROIX-CHEVALIERDC80218-362026-07-12
03661219527046DELACROIX-CHEVALIERDC81922-002026-07-12
03661219528371LANDANGERDC80252-302026-07-12
03661219140238DELACROIX-CHEVALIERDC50411-182026-07-08
03661219141648DELACROIX-CHEVALIERDC51150-262026-07-08
03661219143482DELACROIX-CHEVALIERDC80001-362026-07-08
03661219317715DELACROIX-CHEVALIERDC83213-442026-07-08
03661219389781DELACROIX-CHEVALIERDC50703-23TI2026-07-08
03661219389989DELACROIX-CHEVALIERDC50710-18TI2026-07-08
03661219390220DELACROIX-CHEVALIERDC50713-18TI2026-07-08
03661219436522LANDANGERJ01471-232026-07-08
03661219436584LANDANGERJ01473-232026-07-08
03661219436706LANDANGERJ01477-232026-07-08
03661219510000DELACROIX-CHEVALIERDC85515-352026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776403973MillenniumAvalign Technologies, Inc.DWS2026-07-22
00198506091988ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00198506093470ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-22
00840456215753JMUJMU DENTAL, INCMDM2026-07-22
00840456218600JMUJMU DENTAL, INCMDM2026-07-22
00840456218617JMUJMU DENTAL, INCMDM2026-07-22
00190776403348MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403683MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403744MillenniumAvalign Technologies, Inc.MDM2026-07-21
00190776403768MillenniumAvalign Technologies, Inc.DWS2026-07-21
00810005668125TrigonNVision Biomedical Technologies, Inc.MDM2026-04-24
00810005667227TrigonNVision Biomedical Technologies, Inc.MDM2025-12-19
00810135963169ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963183ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963251ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135963275ImpactNVision Biomedical Technologies, Inc.MDM2025-09-22
00810135962865TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962889TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962896TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962902TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962919TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962926TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135962933TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810135963435TrigonNVision Biomedical Technologies, Inc.MDM2025-07-25
00810005668040Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963046Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963053Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963060Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963077Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21
00810135963084Caliber Intramedullary Fixation SystemNVision Biomedical Technologies, Inc.MDM2025-07-21