| Primary Device ID | 05060183095588 |
| NIH Device Record Key | 846c6272-e38a-4a99-a26a-413ce6cce9b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Osteotec Silicone Finger - Osteotec All In One Silicone Finger Set |
| Version Model Number | OSTF-INS9 |
| Catalog Number | OSTF-INS9 |
| Company DUNS | 348489386 |
| Company Name | OSTEOTEC LIMITED |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060183095588 [Primary] |
| OJH | Orthopedic Tray |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
[05060183095588]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-11 |
| Device Publish Date | 2024-01-03 |
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| 05060183090019 - Osteotec Silicone Finger Implant - Size 0 | 2022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis |
| 05060183090026 - Osteotec Silicone Finger Implant - Size 1 | 2022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis |
| 05060183090033 - Osteotec Silicone Finger Implant - Size 2 | 2022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis |
| 05060183090040 - Osteotec Silicone Finger Implant - Size 3 | 2022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis |
| 05060183090057 - Osteotec Silicone Finger Implant - Size 4 | 2022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis |