| 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 |
| M248119580ND1 - I.CO.S® | 2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 4.0mm compression screw h |
| M248119590ND1 - I.CO.S® | 2024-04-03 The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 6.5mm compression screw h |
| M248139107ND1 - METIS® | 2024-02-07 The metatarsal osteotome is used to cut the bone after the pre-cutting stage with the cutting guide, for the insertion of the im |
| M248529061ND1 - SURFIX® | 2023-09-18 This K-Wire of diameter 2.5 mm and of length 250 mm is used to guide the instrumentation and the screws. |
| 10381780043317 - BASAL DORSAL PLATE | 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is |
| 10381780043324 - BASAL DORSAL PLATE | 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is |
| 10381780043331 - BASAL DORSAL PLATE | 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is |
| 10381780043348 - BASAL DORSAL PLATE | 2023-09-18 The Newdeal sterile Basal Dorsal Plate consists of an osteosynthesis plate designed to bridge the tarsometatarsal joints. It is |