FDA.report

DELACROIX-CHEVALIER

Primary DI
03661219511373
Brand
DELACROIX-CHEVALIER
Company
LANDANGER
Model
DC81351-30
Published
2024-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications

CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03661219511373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03661219511373036612195113733661219511373

GMDN Terms

TermDefinition
Eustachian catheter, reusableA long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown from an external bag through the device and into the middle ear. It is typically made of soft metals [e.g., silver (Ag) coated brass], and has a curved distal end with a slightly bulbous tip and a wider funnel-like proximal end with a finger ring to aid manipulation. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
299889175
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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03661219528289DELACROIX-CHEVALIERDC30149-03DC30159-032026-01-12
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03661219528692DELACROIX-CHEVALIERDC33030-022026-03-19
03661219528708DELACROIX-CHEVALIERDC33030-032026-03-19
03661219528715DELACROIX-CHEVALIERDC33030-042026-03-19
03661219322184DELACROIX-CHEVALIERDC83002-442026-03-16
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Primary DIBrandCompanyProduct codePublished
24026704941593PILLINGTELEFLEX INCORPORATEDDWS2026-03-23
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03661219511618DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511649DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511694DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219511809DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
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03661219515425DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219515968DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528685DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528692DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528708DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
03661219528715DELACROIX-CHEVALIERLANDANGERDWS2026-03-19
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00198506088957ELMED INCORPORATEDELMED INCORPORATEDDWS2026-03-03
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03661219138518DELACROIX-CHEVALIERLANDANGERDWS2026-03-02
03661219138556DELACROIX-CHEVALIERLANDANGERDWS2026-03-02