EZ-TRAX™
GUDID 00850025473705
Insert Aluminum (L)24 (W)12 (H)2
K1 MEDICAL TECHNOLOGIES, LLC
Instrument tray, reusable| Primary Device ID | 00850025473705 |
| NIH Device Record Key | 11bf61ff-7840-43fc-b231-bc23604d5cd2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EZ-TRAX™ |
| Version Model Number | 137 INSERT.AL.24.12.2 |
| Company DUNS | 080448429 |
| Company Name | K1 MEDICAL TECHNOLOGIES, LLC |
| 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 | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850025473705 [Primary] |
FDA Product Code
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
[00850025473705]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-20 |
| Device Publish Date | 2021-05-12 |
On-Brand Devices [EZ-TRAX™]
| 00850006159581 | POST |
| 00850006159574 | THA Broachs |
| 00850006159567 | THA Broachs |
| 00850006159550 | TKA Pin Caddy |
| 00850006159543 | TKA Tibia Trial Insert |
| 00850006159536 | TKA Trial Base |
| 00850006159369 | Divider (H) 2.4 x (L) 20 |
| 00850006159314 | Divider (H) 2.4 x (L) 15 |
| 00850006159307 | Divider (H) 2.4 x (L) 14 |
| 00850006159284 | Divider (H) 2.4 x (L) 12 |
| 00850006159260 | Divider (H) 2.4 x (L) 10 |
| 00850006159246 | Divider (H) 2.4 x (L) 08 |
| 00850006159222 | Divider (H) 2.4 x (L) 06 |
| 00850006159215 | Divider (H) 2.4 x (L) 05 |
| 00850006159208 | Divider (H) 2.4 x (L) 04 |
| 00850006159192 | Divider (H) 2.4 x (L) 03 |
| 00850006159185 | Divider (H) 2.4 x (L) 02 |
| 00850006159512 | Bracket Silicone (H) 2.4 Standard Round Dia. 1.00 |
| 00850006159505 | Bracket Silicone (H) 2.4 Standard Round Dia. .875 |
| 00850006159499 | Bracket Silicone (H) 2.4 Standard Round Dia. .750 |
| 00850006159475 | Bracket Silicone (H) 2.4 Standard Round Dia. .500 |
| 00850006159451 | Bracket Silicone (H) 2.4 Standard Round Dia. .4375 |
| 00850006159437 | Bracket Silicone (H) 2.4 Standard Round Dia. .375 |
| 00850006159413 | Bracket Silicone (H) 2.4 Standard Round Dia. .250 |
| 00850006159383 | Bracket Silicone (H) 2.4 Standard Round Dia. 2mm |
| 00850025473026 | Bracket Assembly Hip Broaches 6 Slots |
| 00850025473002 | Bracket Assembly Hip Broaches 5 Slots |
| 00850006159819 | BRACKET (H) 2 x (L) 10 x (P) 002 |
| 00850006159802 | BRACKET (H) 2 x (L) 10 x (P) 001 |
| 00850006159796 | BRACKET (H) 2 x (L) 02 x (P) 002 |
| 00850006159789 | BRACKET (H) 2 x (L) 02 x (P) 001 |
| 00850025473125 | Base Assembly Aluminum (L)25 (W)12 (H)4 |
| 00850025473118 | Base Assembly Aluminum (L)20 (W)11 (H)6 |
| 00850025473057 | Bracket Aluminum (H) 2 x (L) 20 x (P) 116 |
| 00850025473040 | Bracket Aluminum (H) 2 x (L) 20 x (P) 115 |
| 00850025473033 | Bracket Aluminum (H) 2 x (L) 20 x (P) 114 |
| 00850025473019 | Post 1 PC Size .172 |
| 00850025473149 | Lid Assembly Aluminum (L)25 (W)12 |
| 00850025473132 | Lid Assembly Aluminum (L)20 (W)11 |
| 00850025473064 | Insert Aluminum (L)21 (W)12 (H)2 |
| 00850025473705 | Insert Aluminum (L)24 (W)12 (H)2 |
| 00850025473460 | BRACKET INSERT SILICONE 80 (H) 2.4 (W) 1.550 STANDARD ROUND DIA. .3125 |
| 00850025473453 | BRACKET INSERT SILICONE 80 (H) 2.4 (W) 1.550 STANDARD ROUND DIA. .250 |
| 00850025473439 | BRACKET INSERT SILICONE 80 (H) 2.4 (W) 1.550 STANDARD ROUND DIA. .130 |
| 00850025473422 | BRACKET INSERT SILICONE 80 (H) 2.4 (W) 1.550 STANDARD ROUND DIA. .0625 |
| 00850025473187 | BRACKET INSERT SILICONE 80 (H) 2.4 (W) 1.550 STANDARD ROUND DIA. .4375 |
| 00850025473163 | BRACKET INSERT SILICONE 80 (H) 2.4 (W) 1.550 STANDARD ROUND DIA. .375 |
| 00850006159352 | Divider (H) 2.4 x (L) 19 |
| 00850006159345 | Divider (H) 2.4 x (L) 18 |
| 00850006159338 | Divider (H) 2.4 x (L) 17 |
Trademark Results [EZ-TRAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EZ-TRAX 88113763 not registered Live/Pending |
K1 Medical 2018-09-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.