Primary Device ID | M2482032001 |
NIH Device Record Key | 1e0895b8-fa8c-4659-8324-5835c6e48e8f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | K2™ Hemi Toe Implant System |
Version Model Number | 203200 |
Catalog Number | 203200 |
Company DUNS | 963856096 |
Company Name | INTEGRA LIFESCIENCES CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)654-2873 |
custsvcnj@integralife.com | |
Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Phone | +1(800)654-2873 |
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Device Issuing Agency | Device ID |
---|---|
GS1 | 10381780279440 [Primary] |
HIBCC | M2482032001 [Secondary] |
HTO | REAMER |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
[M2482032001]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-07-23 |
Device Publish Date | 2018-04-10 |
M2482032001 | K2 HEMI REAMER |
M2482050021 | K2 HEMI BASE |
M2482050011 | K2 HEMI LID |
M2482050001 | K2 HEMI TRAY |
M248201040KMI1 | The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in |
M2482010301 | The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in |
M2482010201 | The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in |
M2482010101 | The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in |
M24820310041 | K2™ Hemi Toe Implant System TOE PLATE |
M2482030201 | K2 HEMI SHAPER SIZE 2 |
M24820310051 | K2 HEMI GUIDE SCREW |