FDA.report

HANDLEX

Primary DI
08055002907798
Brand
HANDLEX
Company
MEDAX SRL UNIPERSONALE
Model
HN18070-00
Device description
Bone marrow aspiration biopsy needle 18G x 70MM
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
08055002907798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08055002907798080550029077988055002907798

GMDN Terms

TermDefinition
Bone marrow biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to obtain a specimen of bone marrow percutaneously. The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the hip bone or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. The resultant specimen is typically used for the pathological analysis of the source of blood cellular elements. 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
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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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