FDA.reportPublic FDA data

LANDANGER

Primary DI
03661219280477
Brand
LANDANGER
Company
LANDANGER
Model
O617011
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
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661219280477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661219280477036612192804773661219280477

GMDN Terms#

Term, Definition table
TermDefinition
Device operating status label/tag, single-useA label or a tag intended to indicate/collect the operating status of a device to which it is attached; it does not include any additional functionality and does not include a sterilization process indicator. It is typically constructed from a durable material and may be designed as a locking tag. This is a single-use 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
03661219327929LANDANGERO6118422026-10-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD903260200Surgical DirectSurgical Direct, Inc.DWS2026-10-28
00724995264819Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264826Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264833Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264840Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995264857Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265564Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265571Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995265588Snowden-PencerSTERIS Deutschland GmbHDWS2026-10-27
00724995278977V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279004V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279042V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279059V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279066V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995279080V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280093V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280826V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280871V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280895V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280901V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280918V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280925V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995280987V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281045V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281229V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281243V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281250V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281267V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281274V. MuellerSTERIS Deutschland GmbHDWS2026-10-27
00724995281281V. MuellerSTERIS Deutschland GmbHDWS2026-10-27