FDA.reportPublic FDA data

ARVIS ®

Primary DI
00850012315070
Brand
ARVIS ®
Company
KICO KNEE INNOVATION COMPANY PTY LIMITED
Model
10300
Device description
Reference Tracker 1
Published
2021-11-12
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

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012315070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012315070008500123150708500123150700850012315070

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical tracking system spatial marker, reusableA non-powered, noninvasive component of a surgical navigation and/or tracking system (e.g., computer-assisted surgical ultrasound system, surgical microscope) intended for preoperative and/or intraoperative use to function as an optical reference to enable spatial registration/tracking of the position/movement/size of a patient, another marker, and/or surgical instrument (e.g., stereotactic surgery probe). It may be attached to the patient, another marker or surgical instrument, and may contain features (e.g., reflective spheres, contrast patterns) detectable by a tracking camera. Procedural supportive devices (e.g., drapes) may be included with the device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
757918953
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810180350051ARVIS ®IN-280502025-11-17
00810180350099ARVIS ®IN-281002025-11-17
00810180350112ARVIS ®IN-281302025-11-17
00810180350013ARVIS ®IN-226002025-07-29
00810180350266ARVIS ®IN-240002025-05-23
00810180350433ARVIS ®IN-186002025-05-23
00810180350525ARVIS ®IN-164002025-05-23
00810180350556ARVIS ®IN-104002025-05-23
00810180350563ARVIS ®IN-161002025-05-23
00810180350693ARVIS ®IN-106002025-05-23
00810180350280ARVIS ®IN-221002025-03-18
00850012315865ARVIS ®240002024-06-17
00850012315889ARVIS ®221002024-06-17
00850012315650ARVIS ®186002023-09-28
00850012315391ARVIS ®161002022-02-16
00850012315506ARVIS ®164002022-02-16
00850012315513ARVIS ®165002022-02-16
00850012315056ARVIS ®101002021-11-12
00850012315087ARVIS ®104002021-11-12
00850012315100ARVIS ®106002021-11-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
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