FDA.report

NA

Primary DI
04546540364623
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
6001-200-010
Catalog number
6001-200-010
Device description
SKULL POST
Published
2016-08-24
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
04546540364623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04546540364623045465403646234546540364623

GMDN Terms

TermDefinition
Surgical navigation device tracking system cranial localizer holderA non-sterile component of a surgical navigation device tracking system (e.g., optical device tracking system, electromagnetic device tracking system) intended for short-term (= 30 days) stable fixation of a localizer/tracker to the skull during computer assisted surgery (CAS). It is made of titanium (Ti) and typically has components for fixation onto the skull (e.g., self-drilling screws) and for attachment of the localizer/tracker that allow rotation (e.g., connecting pins). This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length2Millimeter

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
false
Manufacturing date on label
false
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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