FDA.report

FRANSEEN

Primary DI
18055002906576
Brand
FRANSEEN
Company
MEDAX SRL UNIPERSONALE
Model
FR20160-01
Device description
FRANSEEN fine aspiration needle 20G x 160MM
Published
2019-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KNWInstrument, Biopsy

Product Code Classifications

CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18055002906576PackageGS120In Commercial Distribution
08055002906579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1805500290657618055002906576
08055002906579080550029065798055002906579

GMDN Terms

TermDefinition
Body aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
440211428
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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18053329372029FNA FRANSEENFR20080-012023-12-13
18055002906583FNA FRANSEENFR22080-012023-12-13
18059174749368FNA FRANSEENFR20060-012023-12-13
18059174749375FNA FRANSEENFR22060-012023-12-13
18059174748651MEDONEMO18250-00/M2022-11-08
18059174748606UNIVERSAL PLUSUP18200-00/M2022-11-07
18059174748613UNIVERSAL PLUSUP18250-00/M2022-11-07
18059174748620FNA CHIBACH22200-01/M2022-11-07
18059174748637FNA CHIBACH22250-00/M2022-11-07
18059174748644MEDONEMO18200-00/M2022-11-07
18052283958980MEDONEMO14160-K02022-08-04
18059174746985MEDWIREXW20100-1S2022-07-15
18059174742284NEO OXUSEN11100-012021-05-21
18052286423690MEDONE ULTRAMU12120-002021-04-22
18053329376874FNA WESTCOTTWE20160-012021-03-24
18053839011814FNA WESTCOTTWE20080-012021-03-24
18054301668178FNA WESTCOTTWE22080-012021-03-24
18054301668208FNA WESTCOTTWE22160-012021-03-24

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