FDA.report

Set of hoses 2 for NaCl pump

Primary DI
EFID66259610
Brand
Set of hoses 2 for NaCl pump
Company
SIRONA Dental Systems GmbH
Model
6625953
Catalog number
6625953
Published
2023-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EFSUNIT, ORAL IRRIGATION

Product Code Classifications

CodeDeviceSpecialtyClass
EFSUnit, Oral IrrigationDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EFID66259530PrimaryHIBCC0
EFID66259610Unit of UseHIBCC0

GMDN Terms

TermDefinition
Disposable surgical irrigation/aspiration systemA device assembly designed to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites (e.g., for soft-tissue wound or bone debridement, site clearing, bone cement residue removal) with a pulsatile jet of sterile fluid (typically saline). It typically consists of a handpiece with an electrically-powered pump and irrigation/suction controls, tubing, and patient contact devices [typically detachable tips (applicators)] of various shapes and sizes for specific surgical applications. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
340306351
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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