FDA.reportPublic FDA data

LANDANGER

Primary DI
03661219010685
Brand
LANDANGER
Company
LANDANGER
Model
B80085
Published
2025-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661219010685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661219010685036612190106853661219010685

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
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
03661219510062DELACROIX-CHEVALIERDC85530-022026-07-08
03661219510086DELACROIX-CHEVALIERDC85530-042026-07-08
03661219511687DELACROIX-CHEVALIERDC84058-232026-07-04
03661219141440DELACROIX-CHEVALIERDC51110-232026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776397463MillenniumAvalign Technologies, Inc.GAD2026-07-16
07613327651133VersiQuadSTRYKER CORPORATIONGAD2026-07-16
00190776395483MillenniumAvalign Technologies, Inc.GAD2026-07-14
B382SD123750Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123760Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123780Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD124326191140Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209910FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209920FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209923FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907126105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247080T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247112T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD90724711T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907249100Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907284670Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907337510Surgical DirectSurgical Direct, Inc.GAD2026-07-14
G453152901750PEAK MEDICALPeak Medical Distribution Inc.GAD2026-07-14
00198506091872ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-10
00810158211193PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00810158219861PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00888937033687ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033694ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033700ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033717ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033724ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033731ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033748ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033755ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033762ONETRAC LXCoopersurgical, Inc.GAD2026-07-10