FDA.reportPublic FDA data

LANDANGER

Primary DI
03661219512592
Brand
LANDANGER
Company
LANDANGER
Model
9B81050J
Published
2023-09-15
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
03661219512592PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661219512592036612195125923661219512592

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
03661219528906DELACROIX-CHEVALIERDC81420-002026-05-06
03661219528913DELACROIX-CHEVALIERDC81421-002026-05-06
03661219456803DELACROIX-CHEVALIERDC84301-282026-04-16
03661219456827DELACROIX-CHEVALIERDC84301-352026-04-16
03661219528982DELACROIX-CHEVALIERDC80992-322026-04-13
03661219455059LANDANGERE5021052026-04-12
03661219515975DELACROIX-CHEVALIERDC84297-232026-04-10
03661219528722DELACROIX-CHEVALIERDC80936-50F2026-04-10
03661219295334DELACROIX-CHEVALIER9DC81112-202026-04-09
03661219392798DELACROIX-CHEVALIER9DC36904-992026-04-09
03661219437994DELACROIX-CHEVALIER9DC80003-432026-04-09
03661219438007DELACROIX-CHEVALIER9DC80208-432026-04-09
03661219442639DELACROIX-CHEVALIER9DC30421-502026-04-09
03661219442646DELACROIX-CHEVALIER9DC30422-702026-04-09
03661219445593DELACROIX-CHEVALIER9DC80110-442026-04-09
03661219353010DELACROIX-CHEVALIERDC80010-362026-04-02
03661219012597LANDANGERB805252026-03-26
03661219311973LANDANGERO6182272026-03-26
03661219311980LANDANGERO6182282026-03-26
03661219319146LANDANGERO6182082026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00846159039948SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039955SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039962SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039979SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039986SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039993SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040005SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040012SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040029SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040036SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040043SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040050SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040067SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040074SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040081SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040098SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040104SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040111SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040128SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039788SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039795SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039801SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039818SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039825SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039832SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039849SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039856SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039863SCANLAN® ForcepsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039870SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27