FDA.reportPublic FDA data

LANDANGER

Primary DI
03661219077794
Brand
LANDANGER
Company
LANDANGER
Model
J28370
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661219077794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661219077794036612190777943661219077794

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. 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
03661219357063DELACROIX-CHEVALIERE2290062026-07-23
03661219357070DELACROIX-CHEVALIERE2290112026-07-23
03661219357087DELACROIX-CHEVALIERE2290132026-07-23
03661219357094DELACROIX-CHEVALIERE2290152026-07-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183531430BR Surgical, LLCBR Surgical, LLCFZS2026-07-22
00840183532017BR Surgical, LLCBR Surgical, LLCFZS2026-07-22
00840183532024BR Surgical, LLCBR Surgical, LLCFZS2026-07-22
00840183532031BR Surgical, LLCBR Surgical, LLCFZS2026-07-22
18257200087426ALIF DISC PREP,ALLOQUENT - ALIFOrthofix US LLCFZS2026-07-17
18257200104093ALLOQUENT - ALIFOrthofix US LLCFZS2026-07-17
B382SD9147092060Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092120Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092130Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092140Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096450Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096460Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096470Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096510Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096520Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096530Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096540Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096550Surgical DirectSurgical Direct, Inc.FZS2026-07-09
07640139342119ROMEO 2 INSTRUMENTATIONSpineArt SAFZS2025-11-10
04046963939588NOVOCARTAesculap AGFZS2020-04-24
04046963315511NOVOCARTAesculap AGFZS2020-04-23
04046963315528NOVOCARTAesculap AGFZS2020-04-23
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10649111017711SklarSKLAR CORPORATIONFZS2019-03-13
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10649111018084SklarSKLAR CORPORATIONFZS2019-03-13
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10649111018619SklarSKLAR CORPORATIONFZS2019-03-13
10649111161612SklarSKLAR CORPORATIONFZS2019-03-13