FDA.report

BRAINPRO STRYKER

Primary DI
04048223099384
Brand
BRAINPRO STRYKER
Company
Pajunk GmbH Medizintechnologie
Model
6000-024-000
Catalog number
6000-024-000
Device description
6000-024-000
Published
2021-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
04048223028667PreviousGS10
04048223099384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048223028667040482230286674048223028667
04048223099384040482230993844048223099384

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1 770-493-6832info@pajunk-usa.com

Regulatory Flags

DUNS number
317654283
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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