| Primary Device ID | 06972884983035 | 
| NIH Device Record Key | 9005a6ca-7dc9-4e95-a0ce-ab589cd2c135 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | PragmaTool | 
| Version Model Number | 801961500 | 
| Company DUNS | 560430218 | 
| Company Name | Hangzhou Rejoin Mastin Medical Device Co., Ltd. | 
| 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 | true | 
| Manufacturing Date | true | 
| Expiration Date | true | 
| Donation Id Number | true | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 06972884983035 [Primary] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
[06972884983035]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-05-30 | 
| Device Publish Date | 2023-05-22 | 
| 06973877664016 | Retrograde Reamer, D4.0, 9.5mm | 
| 06973877664009 | Retrograde Reamer, D4.0, 9.0mm | 
| 06973877663996 | Retrograde Reamer, D4.0, 8.5mm | 
| 06973877663989 | Retrograde Reamer, D4.0, 7.5mm | 
| 06973877663972 | Retrograde Reamer, D4.0, 7.0mm | 
| 06973877663538 | Retrograde Reamer, D4.0, 8.0mm | 
| 06973877660414 | Retrograde Reamer, Tibia, 9.5mm, S | 
| 06973877660407 | Retrograde Reamer, Tibia, 8.5mm, S | 
| 06973877660391 | Retrograde Reamer, Tibia, 7.5mm, S | 
| 06972884983059 | Retrograde Reamer, Tibia, 9.0mm, S | 
| 06972884983042 | Retrograde Reamer, Tibia, 8.0mm, S | 
| 06972884983035 | Retrograde Reamer, Tibia, 7.0mm, S |