| Primary Device ID | 00810168190112 |
| NIH Device Record Key | 475ff3d0-9486-4843-a4b7-64f57d444409 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | PI-1672 |
| Company DUNS | 621872006 |
| Company Name | PACIFIC INSTRUMENTS, INC. |
| 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 | 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 | 00810168190112 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
[00810168190112]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-30 |
| Device Publish Date | 2025-05-22 |
| 00810168190112 - NA | 2025-05-30Distraction Screw, 14mm |
| 00810168190112 - NA | 2025-05-30 Distraction Screw, 14mm |
| 00850005084952 - NA | 2025-04-25 12 Inch Scalpel |
| 00850005084969 - NA | 2025-04-25 6.0 Double Action Rod Gripper |
| 00850005084983 - NA | 2025-04-18 Bone Holding Forceps |
| 00850005084990 - NA | 2025-04-18 Bone Reduction Forceps, Curved, Pointed Tips, 131mm OAL |
| 00850005084938 - NA | 2024-12-26 Sure Grip 120, OAL 197mm, AO QC, Ratcheting, Cannulated |
| 00850005084921 - NA | 2024-11-14 TBD |
| 00850005084723 - NA | 2024-10-08 Ø4.0mm Carbide Drill Bit 75 mm OAL, Left Hand |