FDA.reportPublic FDA data

PROFESS

Primary DI
07613252727026
Brand
PROFESS
Company
Stryker Leibinger GmbH & Co. KG
Model
6001-410-070
Catalog number
6001-410-070
Device description
PROFESS(TM) CURVED 70¿ SUCTION
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PGWEar, Nose, and Throat Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGWEar, Nose, And Throat Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252727026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252727026076132527270267613252727026

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic surgery system probe, single-useA long, sterile, slender, rod-like device made of metal and/or plastic, 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 single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify005V
Special Storage Condition, Specify00TRANSPORT:10-90%/-20-50¿C/50-106KPA
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature4 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327711578NA92-5577292-557722026-09-24
07613327711585NA92-5577392-557732026-09-24
07613327711592NA92-5577192-557712026-09-24
07613327711608NA92-5577092-557702026-09-24
04546540337818DELTA70-7132470-713242016-08-24
04546540337825DELTA70-7132670-713262016-08-24
04546540337900DELTA70-7182270-718222016-08-24
07613327097627CranialMask Tracker6000-390-0006000-390-0002017-03-13
07613327499711N/A8900-200-2008900-200-2002023-03-23
07613327551938N/A6002-710-0506002-710-0502022-07-26
07613327620306N/A6002-810-5006002-810-5002025-10-28
07613327616118N/A6002-810-0006002-810-0002024-08-22
07613327616255N/A6002-810-3006002-810-3002024-08-15
07613327616286N/A81-8104481-810442024-08-15
07613327638189N/A6002-810-1006002-810-1002024-08-15
07613327638196N/A6002-810-2006002-810-2002024-08-15
07613327579833N/A7000015775827000015775822024-08-07
07613327576542N/A8800-100-0008800-100-0002023-04-11
07613327500530N/A8000-060-0198000-060-0192023-03-24
07613327500615N/A8000-060-0168000-060-0162023-03-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000738389AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
00763000738396AxiEM™MEDTRONIC NAVIGATION, INC.PGW2026-02-15
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04260759930331FlexTube 4mmFiagon GmbHPGW2025-01-16
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04260759930126VirtuEyeFiagon GmbHPGW2024-09-02
04260759930256Navigation Headrest UniversalFiagon GmbHPGW2024-09-02
04260759930362PointerShell 4 mm Fiagon GmbHPGW2024-09-02
04260759930379PointerShell 5 mm Fiagon GmbHPGW2024-09-02
04260759930386PointerShell 3 mm Fiagon GmbHPGW2024-09-02
04260759930393PointerShell UniversalFiagon GmbHPGW2024-09-02
14260759930512Adhesive PadFiagon GmbHPGW2024-09-02