| Primary Device ID | 00850039930058 |
| NIH Device Record Key | 9ec5d907-1d74-4e53-b71b-495c63dfb2a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pathfinder™ ACL System |
| Version Model Number | 0180R |
| Catalog Number | 0180R |
| Company DUNS | 080919105 |
| Company Name | Danamed, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 | 00850039930058 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
[00850039930058]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-24 |
| Device Publish Date | 2023-02-16 |
| 00850039930058 | Pathfinder ACL Guide, Left Knee, 8 mm offset |
| 00850039930041 | Pathfinder ACL Guide, Right Knee, 8 mm offset |
| 00850039930034 | Pathfinder ACL Guide, Left Knee, 7 mm offset |
| 00850039930027 | Pathfinder ACL Guide, Right Knee, 7 mm offset |
| 00850039930010 | Pathfinder ACL Guide, Left Knee, 5.5mm offset |
| 00850039930003 | Pathfinder ACL Guide, Right Knee, 5.5mm offset |
| 50850039930060 | Flexible Guide Pin with Sheath Adaptor, 1 Guide Pin, 1 Sheath |
| 40850039930063 | Flexible Guide Pin with Sheath Adaptor, 2 Guide Pins, 2 Sheaths |
| 30850039930066 | Flexible Guide Pin with Sheath Adaptor, 3 Guide Pins, 3 Sheaths |
| 20850039930069 | Flexible Guide Pin with Sheath Adaptor, 4 Guide Pins, 4 Sheaths |
| 10850039930062 | Flexible Guide Pin with Sheath Adaptor, 5 Guide Pins, 5 Sheaths |
| 00850039930065 | Flexible Guide Pin with Sheath Adaptor, 1 Guide Pin, 1 Sheath |