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
03661219011590LANDANGERB803202026-10-19
03661219455073LANDANGERE5030052026-10-19
03661219013341LANDANGERB807752026-10-15
03661219008224LANDANGERB504492026-10-12
03661219389811DELACROIX-CHEVALIERDC50704-182026-10-12
03661219510024DELACROIX-CHEVALIERDC85521-302026-10-12
03661219525486DELACROIX-CHEVALIERDC81377-272026-10-12
03661219525509DELACROIX-CHEVALIERDC81376-272026-10-12
03661219525523DELACROIX-CHEVALIERDC81375-272026-10-12
03661219525547DELACROIX-CHEVALIERDC81374-272026-10-12
03661219525561DELACROIX-CHEVALIERDC81373-272026-10-12
03661219525585DELACROIX-CHEVALIERDC81372-272026-10-12
03661219525608DELACROIX-CHEVALIERDC81371-272026-10-12
03661219525943DELACROIX-CHEVALIERDC81030-052026-10-12
03661219525950DELACROIX-CHEVALIERDC81030-042026-10-12
03661219525967DELACROIX-CHEVALIERDC81030-032026-10-12
03661219525974DELACROIX-CHEVALIERDC81030-022026-10-12
03661219525981DELACROIX-CHEVALIERDC81030-012026-10-12
03661219527442DELACROIX-CHEVALIERDC81030-062026-10-12
03661219320265DELACROIX-CHEVALIERDC83211-442026-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436674MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776436704MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776437657MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776437770MillenniumAvalign Technologies, Inc.DWS2026-10-20
00190776437794MillenniumAvalign Technologies, Inc.DWS2026-10-20
03661219455073LANDANGERLANDANGERDWS2026-10-19
03661219008224LANDANGERLANDANGERDWS2026-10-12
03661219389811DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219510024DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525486DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525509DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525523DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525547DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525561DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525585DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525608DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525943DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525950DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525967DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525974DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525981DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219527442DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
04058749009897NAFehling Instruments GmbH & Co. KGDWS2026-10-12
04058749125931NAFehling Instruments GmbH & Co. KGDWS2026-10-12
03661219320265DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219438601DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219442943DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219528388DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
00190776434236MillenniumAvalign Technologies, Inc.DWS2026-10-09
00190776436216MillenniumAvalign Technologies, Inc.DWS2026-10-08