| Primary Device ID | M248119555ND1 |
| NIH Device Record Key | 26b3a6d5-94ab-42e8-8460-76b18d35bfc0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | I.CO.S® |
| Version Model Number | 119555ND |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780051848 [Primary] |
| HIBCC | M248119555ND1 [Secondary] |
| HWX | TAP, BONE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M248119555ND1]
Moist Heat or Steam Sterilization
[M248119555ND1]
Moist Heat or Steam Sterilization
[M248119555ND1]
Moist Heat or Steam Sterilization
[M248119555ND1]
Moist Heat or Steam Sterilization
[M248119555ND1]
Moist Heat or Steam Sterilization
[M248119555ND1]
Moist Heat or Steam Sterilization
[M248119555ND1]
Moist Heat or Steam Sterilization
[M248119555ND1]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2017-05-26 |
| M248119592ND1 | The internal extractor, with a trocar tip and a three 2.6mm/120° flat pan attachment, is insert |
| M248119582ND1 | The internal extractor, with a trocar tip and a three 1.75mm/120° flat pan attachment, is inser |
| M248119552ND1 | The external protection sleeve is used to protect the soft tissues while drilling the bone for t |
| M248119551ND1 | The internal protecting sleeve is used to protect the soft tissues while drilling the bone for t |
| M248119541ND1 | The drilling guide is used to guide the drill as well as to protect the soft tissues while drill |
| M248119506ND1 | The drilling guide is used to guide the drill as well as to protect the soft tissues while drill |
| M248119501ND1 | The protection sleeve is used to protect the soft tissues while drilling the bone for the 4.0mm |
| M248119988ND1 | The silicone carpet is part of the base with reference 119986ND used in the transport and the st |
| M248119986ND1 | The silicone base is part of the container with reference 119985ND used in the transport and the |
| M248119985ND1 | The stainless steel complete box is used in the transport and the sterilization of the I.CO.S® |
| M248119984ND1 | The radel insert is part of the container with reference 119985ND used in the transport and the |
| M248119977ND1 | The propylux cylinder maintains the K-wires in the removal set with reference 119975ND used in t |
| M248119976ND1 | The complete box is used in the transport and the sterillization of the I.CO.S® 6.5mm compressi |
| M248119974ND1 | The complete box is used in the transport and the sterillization of the I.CO.S® 4mm compression |
| M248119959ND1 | The lid is part of the removal set with reference 119975ND used in the transport and the sterili |
| M248119958ND1 | The base is part of the container with reference 119976ND used in the transport and the sterilli |
| M248119957ND1 | The radel lid is part of the container used in the transport and the sterillization of the I.CO |
| M248119956ND1 | The silicone base is part of the container with reference 119974ND used in the transport and the |
| M248119955ND1 | The base is part of the removal set with reference 119975ND. It is used in the transport and the |
| M248119953ND1 | The radel insert is part of the container with reference 119976ND used in the transport and the |
| M248119951ND1 | The radel insert is part of the container with reference 119974ND used in the transport and the |
| M248119572ND1 | The cannulated graduated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, |
| M248119571ND1 | The long cannulated graduated drill, with a three lip tip and a 6.0mm diameter tri shank attachm |
| M248119546ND1 | The short cannulated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, is u |
| M248119522ND1 | The short cannulated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, is u |
| M248119516ND1 | The long cannulated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, is us |
| M248119555ND1 | The cannulated internal tap is used to prepare the thread of the 6.5mm compression screws. It is |
| M248119525ND1 | The cannulated internal tap is designed to prepare the thread of the 4mm compression screw heads |
| M248119590ND1 | The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone arou |
| M248119580ND1 | The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone arou |