FDA.reportPublic FDA data

NA

Primary DI
04546540387356
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
6001-380-000
Catalog number
6001-380-000
Device description
MASK COMMUNICATION UNIT
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HAWNeurological stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540387356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540387356045465403873564546540387356

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning sensorA device designed to detect and respond to movement and transmits a signal proportional to the degree of motion. A parent device will receive these signals and show the position of the sensor and the object to which it is attached and make the necessary display/control adjustments for the object being monitored. It may be permanently attached to an electrical cable that relays energy to the sensor and signals back to the parent device. It may be affixed to the leg of a patient during computer assisted surgery (CAS) for implantation of a hip prosthesis to assist in the correct positioning of the implant or as a component of an electromagnetic device tracking system. This is a reusable device.

Storage And Handling#

Type, Low, High table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540256805NA62-0053462-005342016-10-19
04546540356529NA60-1605060-160502016-08-24
04546540356628NA62-0030262-003022016-12-08
07613154185443NA62-0044162-004412016-12-08
07613252313069DELTA70-9200970-920092015-09-24
07613252444220DELTA70-9200670-920062015-09-24
07613252444244DELTA70-9200370-920032015-09-24
07613327090123NA62-2014962-201492016-10-19
07613327090192NA62-2013962-201392016-10-19
07613327123340Delta70-9205670-920562015-09-24
07613327123364Delta70-9205570-920552015-09-24
04546540366788NA62-2052062-205202016-10-19
04546540391391NA62-0020862-002082016-12-08
07613154731800NA92-1592392-159232017-01-11
07613154732685NA92-1592192-159212017-01-11
07613252727002DELTA70-9204770-920472015-09-24
07613252286578FLUOROMAP6006-600-0006006-600-0002025-01-28
07613327542202N/A81-8007081-800702023-05-11
07613327542219N/A6003-700-3006003-700-3002023-05-11
07613327542363N/A6003-710-3006003-710-3002023-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340201503829Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503836Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503843Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
00889024713895ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2026-09-28
00889024714113PLANNING STATION - USAMEDTECHHAW2026-09-28
00889024704213PLANNING STATION - USAMEDTECHHAW2026-02-23
04056481146702Curve NavigationBrainlab SEHAW2025-10-13
00889024679559ALLEN WRENCH 8MMMEDTECHHAW2025-07-15
00887868539978SEEG DRILL ADAPTOR 2.70MMMEDTECHHAW2025-06-24
00889024663282PLANNING STATION - ROSA ONE - USAMEDTECHHAW2024-02-20
00887868585951ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2023-10-30
03760244031129Trnsnsl Endscp Ovoid Ø6.18mm HolderMEDTECHHAW2023-10-27
04056481144500Curve Navigation 17700Brainlab SEHAW2023-05-22
03760244034793ROSA ONE SURGICAL ASSISTANT (US)MEDTECHHAW2022-06-20
03760244034922PLANNING STATION-ROSA ONE- USAMEDTECHHAW2022-06-20
03760244035127PLANNING STATION-ROSA ONE- USAMEDTECHHAW2022-06-20
03760244034625SEEG DRILL ADAPTOR Ø2.5MMMEDTECHHAW2022-02-18
03760244034632SEEG DRILL ADAPTOR Ø2.15MMMEDTECHHAW2022-02-18
03760244034649SEEG DRILL ADAPTOR Ø2.45MMMEDTECHHAW2022-02-18
03760244034656SEEG DRILL ADAPTOR Ø2.55MMMEDTECHHAW2022-02-18
03760244034663SEEG DRILL ADAPTOR Ø3.2MMMEDTECHHAW2022-02-18
03760244032195Optical distance sensorMEDTECHHAW2021-06-15
03760244034304ROBOT ROSA ONE (USA)MEDTECHHAW2021-05-31
03760244034403PLANNING STATION Rosa One -USAMEDTECHHAW2021-05-31
04056481143503Kick 2 Navigation StationBrainlab SEHAW2021-05-31
03760244030962CRW frame adaptorMEDTECHHAW2020-11-20
03760244031914LEKSELL FRAME REGISTRATION PLATESMEDTECHHAW2020-10-20