FDA.report

Disposable Biopsy Needle

Primary DI
04048223028667
Brand
Disposable Biopsy Needle
Company
Pajunk GmbH Medizintechnologie
Model
6000-024-000
Catalog number
6000-024-000
Device description
DBZ Sedan Diameter 2.5mm / Length 210mm Ø 1,8 x 250mm
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HAWNeurological stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048223028667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048223028667040482230286674048223028667

GMDN Terms

TermDefinition
Brain biopsy procedure kitA packaged collection of sterile equipment that includes a disposable brain biopsy needle and other supplies used to perform a stereotaxic sampling of brain tissue. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)972-5865info@pajunk-usa.com

Regulatory Flags

DUNS number
317654283
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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