| Primary Device ID | 00840118126199 |
| NIH Device Record Key | 74f0ec8c-5cad-49e9-b53d-055e37a0ae8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Active Compression |
| Version Model Number | OTP055 |
| Company DUNS | 078790947 |
| Company Name | FLOWER ORTHOPEDICS CORPORATION |
| 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 | false |
| Manufacturing Date | false |
| 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 | 00840118126199 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840118126199]
Moist Heat or Steam Sterilization
[00840118126199]
Moist Heat or Steam Sterilization
[00840118126199]
Moist Heat or Steam Sterilization
[00840118126199]
Moist Heat or Steam Sterilization
[00840118126199]
Moist Heat or Steam Sterilization
[00840118126199]
Moist Heat or Steam Sterilization
[00840118126199]
Moist Heat or Steam Sterilization
[00840118126199]
Moist Heat or Steam Sterilization
[00840118126199]
Moist Heat or Steam Sterilization
[00840118126199]
Moist Heat or Steam Sterilization
[00840118126199]
Moist Heat or Steam Sterilization
[00840118126199]
Moist Heat or Steam Sterilization
[00840118126199]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-09 |
| Device Publish Date | 2025-12-01 |
| 00840118126526 | 7.0mm x 120mm Active Compression Implant |
| 00840118126298 | Small Hudson Adaptor |
| 00840118126199 | 5.5 Tissue Protector, Active Compression |