FDA.reportPublic FDA data

VIPER

Primary DI
10705034388472
Brand
VIPER
Company
Medos International Sàrl
Model
286715450N
Catalog number
286715450N
Device description
UNIVERSAL NAVIGATION VIPER SYSTEM TAP, DUAL LEAD CANNULATED 4.35mm
Published
2016-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K120867000
K140927000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120867000VIPER AND EXPEDIUM NAVIGATED INSTRUMENTSMedos International SARL2012-09-20OLO
K140927000UNIVERSAL NAVIGATION INSTRUMENTSMedos International SARL2014-10-24OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034388472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503438847210705034388472

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic surgery system probe, reusableA slender, rod-like, hand-held manual surgical instrument intended for use 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 with that of a targeted tissue of interest in a patient so the tissue area is precisely identified with respect to diagnostic images stored in the stereotactic surgery system. It is made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034647807TRIALTIS5161-00-514551610051452026-06-03
10705034647814TRIALTIS5161-00-514451610051442026-06-03
10705034647821TRIALTIS5161-00-514051610051402026-06-03
10705034647838TRIALTIS5161-00-514651610051462026-06-03
10705034648118TRIALTIS5161-00-514151610051412026-06-03
10886705028139NA2420552420552017-03-29
10886705030187NA2426322426322018-02-22
10886705030194NA2426332426332018-02-22
10886705030200NA2426342426342018-02-22
10886705030217NA2426352426352018-02-22
10886705030224NA2426362426362018-02-22
10886705030231NA2426372426372018-02-22
10886705030248NA2426382426382018-02-22
10886705030255NA2426392426392018-02-22
10886705030262NA2426402426402018-02-22
10886705030279NA2426522426522018-02-22
10886705030286NA2426532426532018-02-22
10886705030293NA2426542426542018-02-22
10705034606897TRIALTIS5560886545S5560886545S2026-05-29
10705034608679TRIALTIS5560520004S5560520004S2026-05-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493422428RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422435RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422442RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422459RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422466RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422473RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422480RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422497RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422503RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422510RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422527RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422534RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422541RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422558RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422565RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422572RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
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00840493422268RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
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00840493422282RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422299RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422305RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422312RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422329RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422336RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422343RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422350RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02