| Primary Device ID | 04718005155217 |
| NIH Device Record Key | 1f5f3a39-8558-4897-9e1b-88ded75ba056 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orthopedic manual surgical instrument |
| Version Model Number | 406-0301A |
| Company DUNS | 656775504 |
| Company Name | BAUI 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04718005155217 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04718005155217]
Moist Heat or Steam Sterilization
[04718005155217]
Moist Heat or Steam Sterilization
[04718005155217]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-23 |
| Device Publish Date | 2025-01-15 |
| 04719883854803 | Cup Curette, angled, right |
| 04719883854797 | Cup Curette, angled, left |
| 04719883337306 | 14mm Trial |
| 04719883337290 | 13mm Trial |
| 04719883337283 | 12mm Trial |
| 04719883337276 | 11mm Trial |
| 04719883337269 | 10mm Trial |
| 04719883337252 | 9mm Trial |
| 04719883337245 | 8mm Trial |
| 04719883337238 | 7mm Trial |
| 04719883337221 | 14mm Shaver |
| 04719883337214 | 12mm Shaver |
| 04719883337207 | 10mm Shaver |
| 04719883337191 | 8mm Shaver |
| 04719883337177 | Cage Remover |
| 04718005159888 | Cage Pusher |
| 04718005159871 | Comet Lumbar Implant Driver |
| 04718005159864 | 8mm Osteotome |
| 04718005159857 | Rasp, dual-sided, angled |
| 04718005159840 | Rasp, dual-sided, straight |
| 04718005159833 | Cup Curette |
| 04718005159826 | Curette, rectangular, angled, right |
| 04718005159819 | Curette, rectangular, angled, left |
| 04718005159802 | Curette, rectangular |
| 04718005159789 | 13mm Shaver |
| 04718005159772 | 11mm Shaver |
| 04718005159765 | 9mm Shaver |
| 04718005159758 | 7mm Shaver |
| 04718005159710 | Bone Graft Impactor |
| 04718005159703 | Slap Hammer |
| 04718005159697 | Bone Tamper |
| 04718005159680 | Bone Funnel |
| 04718005155156 | T-Handle |
| 04710577045989 | Lumbar Bone Graft Template |
| 04719883858610 | 5mm Hex Screw Driver(initial tightening) |
| 04719883855428 | 6mm Tap |
| 04719883855411 | 5mm Tap |
| 04719883337429 | 5mm Hex Simple Screw Driver(double-sided) |
| 04719883337399 | 5mm Hex Set Screw Holder |
| 04719883337382 | Rod Holder |
| 04719883337320 | 5.5mmTap (Cannulated) |
| 04719883337313 | 4.5mm Tap (Cannulated) |
| 04719883333063 | Rachet Handle |
| 04718005155484 | Torque Wrench 3N-m |
| 04718005155330 | Caliper |
| 04718005155309 | Rod Gripper |
| 04718005155262 | Gun-type Pull-up Pliers |
| 04718005155255 | 5mm Rotator Bar |
| 04718005155248 | Rod Pusher |
| 04718005155231 | 3mm Hex Screw Driver |