| Primary Device ID | 04719878787130 | 
| NIH Device Record Key | 015f08c3-59d4-40b5-8237-231ba97ccc0e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | “Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) | 
| Version Model Number | 428-0800 | 
| Catalog Number | 428-0800 | 
| Company DUNS | 657397790 | 
| Company Name | Paonan Biotech 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 | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| 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 | 04719878787130 [Primary] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
[04719878787130]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-04-23 | 
| Device Publish Date | 2024-04-15 | 
| 04719889594178 | Ratcheting Cannulated I Handle | 
| 04719884699953 | Reduction Forceps | 
| 04719884699366 | 13 Nm Torque Wrench | 
| 04719884699120 | Torx Screw Driver T15 | 
| 04719884699113 | MIS Rod Holder | 
| 04719884699014 | T2 Anti-rotational Wrench | 
| 04719884698994 | T2 Cannulated Screw Driver | 
| 04719878789622 | Threaded Awl (Metal Handle) | 
| 04719878789554 | Swing Driver | 
| 04719878789301 | Accessory Caddy | 
| 04719878788984 | Cannulated T-Handle | 
| 04719878788694 | Torque Wrench 0.8Nm | 
| 04719878787567 | Nut Holder T27 | 
| 04719878787314 | Compressor | 
| 04719878787130 | Cannulated Screw Adjustment Driver | 
| 04719878787116 | T2 Long Arm Breaker | 
| 04719878787062 | Rotation Wrench | 
| 04719878787055 | Rod Bender | 
| 04719878787017 | Ratcheting T-Handle | 
| 04719878787000 | T2 Cannulated Tap 6.5 mm | 
| 04719878786997 | T2 Cannulated Tap 5.5 mm | 
| 04719878786980 | T2 Cannulated Tap 4.5 mm | 
| 04719878786928 | Ball Tip Sounder | 
| 04719878786911 | Curved Probe | 
| 04719878786904 | Straight Probe | 
| 04719878786881 | Awl with Depth Stop | 
| 04719878786836 | T2 Nut Driver T27 | 
| 04719878786829 | Distractor | 
| 04719878786805 | Rod Template 120 mm | 
| 04719878786768 | Rod Pusher | 
| 04719878786744 | T2 Screw Head Compress |