FDA.report

NA

Primary DI
04546540245809
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
6001-022-000
Catalog number
6001-022-000
Device description
POINTER, RIGHT POSTERIOR-FOSSA
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HAWNeurological stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04546540245809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04546540245809045465402458094546540245809

GMDN Terms

TermDefinition
Stereotactic surgery system probe, reusableA long, slender, rod-like device made of metal, used during image guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip to that of a targeted tissue of interest within a patient so that this area of tissue is clearly pinpointed with respect to diagnostic images stored in the stereotactic surgery system. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity25 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify003V
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
316153956
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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