Primary Device ID | 00850039930010 |
NIH Device Record Key | 5c6b3f1c-2ebc-407b-a453-bc6e3fefa632 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pathfinder™ ACL System |
Version Model Number | 0155L |
Catalog Number | 0155L |
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 | 00850039930010 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
Moist Heat or Steam Sterilization
[00850039930010]
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 |