FDA.report

Irri clip S120/80K/NANO/RAPIDO

Primary DI
17630055504392
Brand
Irri clip S120/80K/NANO/RAPIDO
Company
Bien-Air Surgery SA
Model
1302844
Catalog number
1302844-010
Published
2023-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GBXCatheter, Irrigation

Product Code Classifications

CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
17630055504392PrimaryGS10
07630055504395Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1763005550439217630055504392
07630055504395076300555043957630055504395

GMDN Terms

TermDefinition
Surgical irrigation tubing set, reusableA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
481597719
Device count
10
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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