FDA.reportPublic FDA data

LANDANGER

Primary DI
03661219432678
Brand
LANDANGER
Company
LANDANGER
Model
J162885
Published
2023-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661219432678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661219432678036612194326783661219432678

GMDN Terms#

Term, Definition table
TermDefinition
Nerve/vessel retractorA hand-held, non-self-retaining surgical instrument intended to be used for retracting a nerve, tendon, or blood vessel to separate it from the surrounding tissue primarily to allow access to other tissues during a surgical intervention. It is a shaft-like metallic instrument with a blunt bulbous or rounded hook-like retraction tip at the distal end, and a handle at the proximal end. It is available in a variety of designs such as, curved, right-angled, or 45 degree angled. This is a reusable device.

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
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
03661219510062DELACROIX-CHEVALIERDC85530-022026-07-08
03661219510086DELACROIX-CHEVALIERDC85530-042026-07-08
03661219511687DELACROIX-CHEVALIERDC84058-232026-07-04
03661219141440DELACROIX-CHEVALIERDC51110-232026-06-25
03661219143499DELACROIX-CHEVALIERDC80002-362026-06-25
03661219266204DELACROIX-CHEVALIERDC50162-21TI2026-06-25
03661219266358DELACROIX-CHEVALIERDC51050-222026-06-25
03661219266969DELACROIX-CHEVALIERDC80002-302026-06-25
03661219528906DELACROIX-CHEVALIERDC81420-002026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850012846710ValveVaultLSI Solutions, Inc.DWS2026-07-08
03661219140238DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219141648DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219143482DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219317715DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219389781DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219389989DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219390220DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510000DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510062DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219510086DELACROIX-CHEVALIERLANDANGERDWS2026-07-08
03661219511687DELACROIX-CHEVALIERLANDANGERDWS2026-07-04
03661219141440DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219143499DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219266204DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219266358DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
03661219266969DELACROIX-CHEVALIERLANDANGERDWS2026-06-25
00884450376171One-Tie®Merit Medical Systems, Inc.DWS2026-06-06
00810220800324Adler Instrument CompanyAdler, Inc.DWS2026-06-02
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00846159040012SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040029SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040036SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28