FDA.reportPublic FDA data

Disposable Biopsy Needle

Primary DI
04048223029503
Brand
Disposable Biopsy Needle
Company
Pajunk GmbH Medizintechnologie
Model
41778C
Catalog number
41778C
Device description
Disposable Biopsy Needle with Marker Plates. For Re-Order: 41779C (5 pcs of 41778C)
Published
2016-09-23
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
04048223108840PackageGS15In Commercial Distribution
14048223029494PackageGS15Not in Commercial Distribution
04048223029503PreviousGS10
04048223098981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048223108840040482231088404048223108840
1404822302949414048223029494
04048223029503040482230295034048223029503
04048223098981040482230989814048223098981

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 770-493-6832info@pajunk-usa.com
+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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