FDA.report

Single Use Surgical Professional

Primary DI
05055299105221
Brand
Single Use Surgical Professional
Company
PELICAN FEMININE HEALTHCARE LIMITED
Model
S343
Catalog number
S343
Device description
Fenestrated Rounded Frazier 12fg 13cm
Published
2016-08-09
Public version status
Update
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

Contact Domains

Product Codes

CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055299105481PackageGS16In Commercial Distribution
05055299105221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055299105481050552991054815055299105481
05055299105221050552991052215055299105221

GMDN Terms

TermDefinition
Surgical/emergency suction cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge12French
Length13Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+440292074740contactus@pelicanfh.co.uk
+440292074740QARA@eakinhealthcare.com

Regulatory Flags

DUNS number
239505063
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05055299100776Single Use Surgical Professional6fgN1006fgN1002016-08-09
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05055299100790Single Use Surgical Professional6fgN140 6fgN140 2016-08-09
05055299100806Single Use Surgical Professional9fgN1409fgN1402016-08-09
05055299100813Single Use Surgical Professional6fgF1406fgF1402016-08-09
05055299100820Single Use Surgical Professional9fgF140 9fgF140 2016-08-09
05055299100837Single Use Surgical ProfessionalS001S0012016-08-09
05055299100844Single Use Surgical ProfessionalS002S0022016-08-09
05055299100851Single Use Surgical ProfessionalS005S0052016-08-09
05055299100868Single Use Surgical ProfessionalS007S0072016-08-09
05055299100875Single Use Surgical ProfessionalS008S0082016-08-09
05055299100882Single Use Surgical ProfessionalS009S0092016-08-09
05055299100899Single Use Surgical ProfessionalS010S0102016-08-09
05055299100905Single Use Surgical ProfessionalS011S0112016-08-09
05055299100912Single Use Surgical ProfessionalS012S0122016-08-09
05055299100929Single Use Surgical ProfessionalS013S0132016-08-09
05055299100936Single Use Surgical ProfessionalS014S0142016-08-09
05055299100943Single Use Surgical ProfessionalS015S0152016-08-09
05055299100998Single Use Surgical ProfessionalS020S0202016-08-09
05055299101001Single Use Surgical ProfessionalS021S0212016-08-09

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