| Primary Device ID | 05060183095809 |
| NIH Device Record Key | 5c3063df-7626-440c-a9f7-8cc4177dc65c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Osteotec SFI Sizer |
| Version Model Number | OSTF-Sizer |
| Catalog Number | OSTF-Sizer |
| 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 | false |
| Serial Number | true |
| 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 | 05060183095809 [Primary] |
| HWT | Template |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05060183095809]
Moist Heat or Steam Sterilization
[05060183095809]
Moist Heat or Steam Sterilization
[05060183095809]
Moist Heat or Steam Sterilization
[05060183095809]
Moist Heat or Steam Sterilization
[05060183095809]
Moist Heat or Steam Sterilization
[05060183095809]
Moist Heat or Steam Sterilization
[05060183095809]
Moist Heat or Steam Sterilization
[05060183095809]
Moist Heat or Steam Sterilization
[05060183095809]
Moist Heat or Steam Sterilization
[05060183095809]
Moist Heat or Steam Sterilization
[05060183095809]
Moist Heat or Steam Sterilization
[05060183095809]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-04 |
| Device Publish Date | 2025-11-26 |
| 05060183095793 - Osteotec SFI Instruments | 2025-12-04 The Osteotec SFI Instruments device are a non-active, non-implantable, invasive device intended to be used as a tool for creatin |
| 05060183095809 - Osteotec SFI Sizer | 2025-12-04The Osteotec SFI Sizer device comprises of eleven evenly scaled sizers, numbered from size 00 to size 9, to match the available sizes of the definitive implant, the Osteotec Silicone Finger Implant. These eleven sizes effectively constitute components of the Osteotec SFI Sizer, which is placed on the market as a single medical device. Each individual sizer is comprised of a blue flexible silicone elastomer. The sizers are used initially as a guide to choosing the correct size of implant and then, once that choice is made, to insert into the prepared joint space to enable the surgeon to check fit and function e.g. range of motion. |
| 05060183095809 - Osteotec SFI Sizer | 2025-12-04 The Osteotec SFI Sizer device comprises of eleven evenly scaled sizers, numbered from size 00 to size 9, to match the available |
| 05060183095588 - Osteotec Silicone Finger - Osteotec All In One Silicone Finger Set | 2024-01-11 Tray of Osteotec Silicone Finger Sizers and Instruments |
| 05060079820355 - Chiroklip wire protector 2 pack blister | 2022-02-14 ChiroKlip is a small butterfly shaped aluminium clip with an adhesive foam covering. It is designed to fold around the end of a |
| 05060183090002 - Osteotec Silicone Finger Implant - Size 00 | 2022-02-14 The Osteotec Silicone Finger Implant is a one-piece, flexible silicone elastomer implant which is placed in the proximal and dis |
| 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 |