FDA.reportPublic FDA data

Perseus

Primary DI
08052675960013
Brand
Perseus
Company
ORTHOKEY ITALIA SRL
Model
20100801
Catalog number
20100801
Device description
Perseus Device Sensor
Published
2021-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192653000PerseusOrthokey Italia S.R.L.2020-09-09OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052675960013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052675960013080526759600138052675960013

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Handle with care. Products should be stored in a clean, cool, dry area, away fromchemical fume
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39055354829customer.service@orthokey.eu

Regulatory Flags#

DUNS number
433594191
Device count
1
DM exempt
true
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
08052675960143Perseus20903101209031012022-08-18
08052675960167Perseus20902610209026102022-08-18
08052675960044Perseus20902503209025032022-01-17
08052675960068Perseus20902609209026092022-01-17
08052675960082Perseus20902801209028012022-01-17
08052675960099Perseus20902901209029012022-01-17
08052675960105Perseus20903002209030022022-01-17
08052675960112Perseus20904601209046012022-01-17
08052675960174Perseus3001101443001101442022-01-17
08052675960181Perseus3001102783001102782022-01-17
08052675960198Perseus3001101983001101982022-01-17
08052675960204Perseus3001103793001103792022-01-17
08052675960020Perseus20902401209024012022-01-14
08052675960037Perseus20902501209025012022-01-14
08052675960051Perseus20902504209025042022-01-14

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Primary DI, Brand, Company table
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00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
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