| Primary Device ID | M248239030ND1 |
| NIH Device Record Key | 22abd2d2-b587-48c4-8ff2-487d16a09172 |
| Commercial Distribution Discontinuation | 2027-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IPP-ON® |
| Version Model Number | 239030ND |
| 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 | 10381780045984 [Primary] |
| HIBCC | M248239030ND1 [Secondary] |
| HWA | IMPACTOR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M248239030ND1]
Moist Heat or Steam Sterilization
[M248239030ND1]
Moist Heat or Steam Sterilization
[M248239030ND1]
Moist Heat or Steam Sterilization
[M248239030ND1]
Moist Heat or Steam Sterilization
[M248239030ND1]
Moist Heat or Steam Sterilization
[M248239030ND1]
Moist Heat or Steam Sterilization
[M248239030ND1]
Moist Heat or Steam Sterilization
[M248239030ND1]
Moist Heat or Steam Sterilization
[M248239030ND1]
Moist Heat or Steam Sterilization
[M248239030ND1]
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 |
| M248239001ND1 | The basis is part of the container which product number is 239000ND and that is used for transpo |
| M248239000ND1 | The container is used for transport and sterilization of instruments and non-sterile implants. |
| M248239022ND1 | The proximal PIP Fusion hand drill is used to prepare the proximal phalanx and to define the siz |
| M248239021ND1 | The distal PIP Fusion hand drill is used to prepare the distal phalanx and to define the size of |
| M248239012ND1 | The proximal PIP Fusion hand drill is used to prepare the proximal phalanx and to define the siz |
| M248239011ND1 | The distal PIP Fusion hand drill is used to prepare the distal phalanx and to define the size of |
| M248239500ND1 | The clamp holder is used to grip the implant. |
| M248239030ND1 | The PIP Fusion handle impactor is used to insert the implant in the distal part. |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() IPP-ON 79056207 3576532 Live/Registered |
NEWDEAL 2007-12-13 |