| Primary Device ID | 04719878789301 |
| NIH Device Record Key | eff8bc0e-631b-4e68-9520-e30d067531c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | “Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) |
| Version Model Number | 406-0009 |
| Catalog Number | 406-0009 |
| 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 | 04719878789301 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
Moist Heat or Steam Sterilization
[04719878789301]
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 |