FDA.report

DELACROIX-CHEVALIER

Primary DI
03661219442141
Brand
DELACROIX-CHEVALIER
Company
LANDANGER
Model
E229121
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03661219356615PrimaryGS10
03661219442141Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03661219356615036612193566153661219356615
03661219442141036612194421413661219442141

GMDN Terms

TermDefinition
Pleuroscopic/mediastinoscopic access cannula, single-useA rigid, single-lumen, surgical instrument intended to be percutaneously inserted through the chest to provide access to the pleural and/or mediastinal cavity to facilitate the introduction of surgical instruments as part of a minimally-invasive procedure; it is not intended for pericardial access. It typically does not include an insufflation backflow valve and is not intended for endoscopic access requiring insufflation. It provides an entry between adjacent ribs and once in place is intended to remain in position for the duration of the procedure. It may include a trocar blade with a sharp or blunt tip designed to assist introduction. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
299889175
Device count
5
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
false

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03661219528265DELACROIX-CHEVALIERDC30147-01DC30147-022026-01-12
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
03661219323747DELACROIX-CHEVALIERDC71201-002026-03-13
03661219010296LANDANGERB655002026-03-02

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00840329837013N/ABLACK & BLACK SURGICAL, INC.GEA2026-01-16
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