| Primary Device ID | 10381780045861 |
| NIH Device Record Key | 0ec76b88-1c1a-48e0-8f95-b71267991802 |
| Commercial Distribution Discontinuation | 2023-03-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | K-WIRE |
| Version Model Number | 115425ND |
| Catalog Number | 115425 |
| Company DUNS | 536935331 |
| Company Name | NEWDEAL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 | true |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if package is damaged |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780045861 [Primary] |
| HTY | PIN, FIXATION, SMOOTH |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
[10381780045861]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-05-02 |
| Device Publish Date | 2018-10-16 |
| M248119510ND1 - I.CO.S® | 2025-04-28 The measurer is used to measure the 150/200mm K-wire in place and decide the compression screw length to implant. It is placed s |
| M248119511ND1 - I.CO.S® | 2025-04-28 The measurer is used to measure the 250mm K-wire in place and decide the compression screw length to implant. It is placed so th |
| M248119532ND1 - I.CO.S® | 2025-04-28 The cannulated graduated screwdriver axis, with a 6.0mm diameter tri shank attachment, is used to power implant the 4.0mm compre |
| M248119536ND1 - I.CO.S® | 2025-04-28 The external cannulated screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw i |
| M248119562ND1 - I.CO.S® | 2025-04-28 The cannulated screwdriver axis, with a 6.0mm diameter tri shank attachment, is used to implant the 6.5mm compression screws. It |
| M248119566ND1 - I.CO.S® | 2025-04-28 The cannulated external screwdriver is used to achieve additional dynamic compression by advancing the outer thread head screw i |
| 10381780045892 - IPP-ON | 2025-03-06 The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis |
| 10381780045908 - IPP-ON | 2025-03-06 The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis |