FDA.reportPublic FDA data

Disposable Biopsy Needle

Primary DI
04048223028643
Brand
Disposable Biopsy Needle
Company
Pajunk GmbH Medizintechnologie
Model
41778B
Catalog number
41778B
Device description
Disposable Biopsy Needle with Marker Plates; For Re-Order: 41779B (5 pcs of 41778B)
Published
2016-08-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060808000BRAINPRO, BRAINPRO ACCESSPAJUNK GmbH Medizintechnologie2006-07-25HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14048223028657PackageGS15Not in Commercial Distribution
04048223028643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404822302865714048223028657
04048223028643040482230286434048223028643

GMDN Terms#

Term, Definition table
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.

Contacts#

Phone, Email table
PhoneEmail
+1(888)972-5865info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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04048223102541UNIPLEX® NANOLINE001156-72001156-722021-04-02
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04048223103449SONOPLEX001185-71001185-712021-04-02
04048223103463SONOPLEX001185-74001185-742021-04-02
04048223103562SONOPLEX001187-74001187-742021-04-02
04048223107058SONOTAP1185-3E0501185-3E0502021-04-02
04048223115756TUOHY1150-7G1031150-7G1032021-07-07
04048223116043SONO MSK1191-4C0501191-4C0502021-07-07
04048223116074SONO MSK1191-4E0701191-4E0702021-07-07
04048223116081SONO MSK1191-4E0901191-4E0902021-07-07
04048223116098SONO MSK1191-4E1001191-4E1002021-07-07
04048223116265SONOTAP II1285-3E0501285-3E0502021-07-07

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