| Primary Device ID | 07649988202278 |
| NIH Device Record Key | e97f394c-9104-4d13-ad09-f71f651242fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FiberLocker PowerUnit - Handpiece |
| Version Model Number | PU7050A1 |
| Company DUNS | 480096456 |
| Company Name | ZuriMED Technologies AG |
| 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 | 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 |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07649988202278 [Primary] |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07649988202278]
Moist Heat or Steam Sterilization
[07649988202278]
Moist Heat or Steam Sterilization
[07649988202278]
Moist Heat or Steam Sterilization
[07649988202278]
Moist Heat or Steam Sterilization
[07649988202278]
Moist Heat or Steam Sterilization
[07649988202278]
Moist Heat or Steam Sterilization
[07649988202278]
Moist Heat or Steam Sterilization
[07649988202278]
Moist Heat or Steam Sterilization
[07649988202278]
Moist Heat or Steam Sterilization
[07649988202278]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-10 |
| Device Publish Date | 2026-02-02 |
| 07649988202209 - FiberLocker PowerUnit - Transfer Shield | 2026-02-10 |
| 07649988202278 - FiberLocker PowerUnit - Handpiece | 2026-02-10 |
| 07649988202278 - FiberLocker PowerUnit - Handpiece | 2026-02-10 |
| 07649988202285 - FiberLocker PowerUnit - Motor Pack | 2026-02-10 |
| 07649988202292 - FiberLocker PowerUnit - Charging Station | 2026-02-10 |
| 07649988202230 - ZuriMED Technologies AG | 2025-02-18 ZuriMED Technologies AG - FiberLocker Implant (SpeedPatch PET) |
| 07649988202247 - ZuriMED Technologies AG | 2025-02-18 ZuriMED Technologies AG - FiberLocker Instrument SN |