FDA.reportPublic FDA data

TELIGEN

Primary DI
10705034604541
Brand
TELIGEN
Company
Medos International Sàrl
Model
286006064S
Catalog number
286006064S
Device description
TELIGEN REDUCED ACCESS
Published
2024-02-10
Public version status
Update
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
HRXArthroscope
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213978000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213978000TELIGEN SystemMedos International SARL2022-10-18HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034604541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503460454110705034604541

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705032266NA2423332423332026-07-22
10886705001309RIGIDFIX BIOCRYL2108162108162015-09-01
10705034647302CROSSNAV CONDUIT3010-21-9963010219962026-07-09
10705034647319CROSSNAV CONDUIT3010-21-9993010219992026-07-09
10705034647326CROSSNAV CONDUIT3010-21-3323010213322026-07-09
10705034647333CROSSNAV CONDUIT3010-21-3313010213312026-07-09
10705034647340CROSSNAV CONDUIT3010-21-2103010212102026-07-09
10705034647357CROSSNAV CONDUIT3010-21-2113010212112026-07-09
10705034647364CROSSNAV CONDUIT3010-21-2123010212122026-07-09
10705034647371CROSSNAV CONDUIT3010-21-2133010212132026-07-09
10705034647388CROSSNAV CONDUIT3010-21-2143010212142026-07-09
10705034647395CROSSNAV CONDUIT3010-21-2153010212152026-07-09
10705034647418CROSSNAV CONDUIT3010-21-2083010212082026-07-09
10705034647425CROSSNAV CONDUIT3010-21-2093010212092026-07-09
10705034647432CROSSNAV CONDUIT3010-21-3203010213202026-07-09
10705034647449CROSSNAV CONDUIT3010-21-3153010213152026-07-09
10705034647456CROSSNAV CONDUIT3010-21-9983010219982026-07-09
10705034647463N/A3010-21-3403010213402026-07-09
10705034647470CROSSNAV CONDUIT3010-21-3013010213012026-07-09
10705034647487CROSSNAV CONDUIT3010-21-3033010213032026-07-09

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Primary DI, Brand, Company table
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00818720013398SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
00840097536699Kinos Aeros InstrumentationRestor3d, Inc.LXH2026-07-20
08809945895304EXULTCorentec Co., LtdLXH2026-07-20
B504SRAR1930S0ArthrexProvisionLXH2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17