| Primary Device ID | M2483481891 |
| NIH Device Record Key | 337499df-ec12-4a3f-9f97-5a8d4375df7b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® Freedom Wrist Arthroplasty System |
| Version Model Number | 348189 |
| Catalog Number | 348189 |
| 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 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780278665 [Primary] |
| HIBCC | M2483481891 [Secondary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
Moist Heat or Steam Sterilization
[M2483481891]
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 | 2018-03-09 |
| M2483480551 | Integra® Freedom Wrist Arthroplasty System Modular Drill Guide |
| M2483481911 | Integra® Freedom Wrist Arthroplasty System Radial Drill Guide, Right |
| M2483481891 | Integra® Freedom Wrist Arthroplasty System Radial Drill Guide, Left |
| M2483481451 | Integra® Freedom Wrist Arthroplasty System Radial Resection Guide Size 2 |
| M2483481441 | Integra® Freedom Wrist Arthroplasty System Radial Resection Guide Size 1 |
| M2483481431 | Integra® Freedom Wrist Arthroplasty System Radial Feeler |
| M2483481371 | Integra® Freedom Wrist Arthroplasty System Radial Trial, Size 3 Right |
| M2483480751 | Integra® Freedom Wrist Arthroplasty System Carpal Reamer, Size 3 |
| M2483480721 | Integra® Freedom Wrist Arthroplasty System Carpal Reamer, Size 2 |
| M2483480701 | Integra® Freedom Wrist Arthroplasty System Carpal Reamer, Size 1 |
| M2483480681 | Integra® Freedom Wrist Arthroplasty System Hamate Feeler |
| M2483480611 | Integra® Freedom Wrist Arthroplasty System Carpal Resection Guide |
| M2483482811 | Integra® Freedom Wrist Arthroplasty System Instrument Case Insert |
| M2483482801 | Integra® Freedom Wrist Arthroplasty System Instrument Case Base |
| M268348345E1 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M268348335E1 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M268348330E1 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M268348325E1 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M268348320E1 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M268348317E1 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M268348315E1 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M2683483451 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M2683483401 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M2683483351 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M2683483301 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M2683483251 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M2683483201 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M2683483171 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M2683483151 | The Integra Freedom Wrist Arthroplasty Screw and Locking Cap are used in the assembly of a carpa |
| M268348200E1 | The Integra Freedom Wrist Arthroplasty screw locking cap is used in an assembly consisting of a |
| M268348240E1 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M268348235E1 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M268348230E1 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M268348225E1 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M268348220E1 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M268348217E1 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M268348215E1 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M2683482001 | The Integra Freedom Wrist Arthroplasty screw locking cap is used in an assembly consisting of a |
| M2683482451 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M2683482401 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M2683482351 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M2683482301 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M2683482251 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M2683482201 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M2683482171 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M2683482151 | The Integra Freedom Wrist Arthroplasty screw is used in the assembly of a carpal plate and carpa |
| M268348299E1 | The Integra Freedom Wrist Arthroplasty carpal implant is used in an assembly consisting of a tit |
| M268348298E1 | The Integra Freedom Wrist Arthroplasty carpal implant is used in an assembly consisting of a tit |
| M268348297E1 | The Integra Freedom Wrist Arthroplasty carpal implant is used in an assembly consisting of a tit |
| M268348296E1 | The Integra Freedom Wrist Arthroplasty carpal implant is used in an assembly consisting of a tit |