| Primary Device ID | M248119309ND1 |
| NIH Device Record Key | ad4e4bbf-bb03-4c94-9ed7-fef22ff2abaa |
| Commercial Distribution Discontinuation | 2027-07-11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FOREFOOT SOLUTIONS™ |
| Version Model Number | 119309ND |
| Company DUNS | 536935331 |
| Company Name | NEWDEAL |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780045915 [Primary] |
| HIBCC | M248119309ND1 [Secondary] |
| HWA | IMPACTOR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M248119309ND1]
Moist Heat or Steam Sterilization
[M248119309ND1]
Moist Heat or Steam Sterilization
[M248119309ND1]
Moist Heat or Steam Sterilization
[M248119309ND1]
Moist Heat or Steam Sterilization
[M248119309ND1]
Moist Heat or Steam Sterilization
[M248119309ND1]
Moist Heat or Steam Sterilization
[M248119309ND1]
Moist Heat or Steam Sterilization
[M248119309ND1]
Moist Heat or Steam Sterilization
[M248119309ND1]
Moist Heat or Steam Sterilization
[M248119309ND1]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2026-02-09 |
| Device Publish Date | 2017-05-26 |
| M248229012ND1 | FF2 TRANSVERSAL CUTTING GUIDE - The transversal cutting guide is used to guide the saw blade dur |
| M248229011ND1 | FF2 LONGITUDINAL CUTTING GUIDE - The longitudinal cutting guide is used to guide the saw blade d |
| M248119301ND1 | The drilling guide is used to guide the drills while preparing the holes for the staples. After |
| 10381780053620 | Non-sterile '2 in 1' shouldered drill to single drive the body of compression screws and shape o |
| 10381780045205 | Non-sterile '2 in 1' shouldered drill to single drive the body of compression screws and shape o |
| 10381780045175 | Non-sterile '2 in 1' shouldered drill to single drive the body of compression screws and shape o |
| 10381780045168 | Non-sterile '2 in 1' shouldered drill to single drive the body of compression screws and shape o |
| M248119903ND1 | The radel implant insert is part of the container used in the transport and the sterilization of |
| M248119902ND1 | The radel upper tray is part of the container used in the transport and the sterilization of the |
| M248119901ND1 | The radel lower tray is part of the container used in the transport and the sterilization of the |
| M248119027SND1 | The sterile 2' in 1' cannulated shouldered drill, with a 4.0mm diameter cylindrical attachment a |
| M248119025SND1 | The sterile 2' in 1' cannulated shouldered drill, with a 4.0mm diameter cylindrical attachment a |
| M248119023SND1 | The sterile 2' in 1' cannulated shouldered drill, with a 4.0mm diameter cilyndrical attachment a |
| M248159027ND1 | The '2 in 1' cannulated shouldered drill, with a 4.5mm diameter A-O attachment and a total lengt |
| M248159004ND1 | The cannulated drill, with a 4.5mm diameter A-O attachment and a total length of 90mm, is used t |
| M248119417ND1 | The 2' in 1' cannulated shouldered drill, with a 6.0mm diameter tri shank attachment and a three |
| M248119415ND1 | The 2' in 1' cannulated shouldered drill, with a 6.0mm diameter tri shank attachment and a total |
| M248119004ND1 | The cannulated drill, with a three lip tip and a 2.5mm diameter cylindrical attachment and a tot |
| M248119309ND1 | The staple impactor is used to impact the staples to ensure that thay are flush with the bone su |