| Primary Device ID | 00840338601612 |
| NIH Device Record Key | 30461279-b6a9-4516-a06d-f9b564b7988a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Made-To-Order |
| Version Model Number | 9028993 |
| Catalog Number | 9028993 |
| Company DUNS | 968990812 |
| Company Name | TORNIER, 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 |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840338601612 [Primary] |
| GAD | RETRACTOR |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840338601612]
Moist Heat or Steam Sterilization
[00840338601612]
Moist Heat or Steam Sterilization
[00840338601612]
Moist Heat or Steam Sterilization
[00840338601612]
Moist Heat or Steam Sterilization
[00840338601612]
Moist Heat or Steam Sterilization
[00840338601612]
Moist Heat or Steam Sterilization
[00840338601612]
Moist Heat or Steam Sterilization
[00840338601612]
Moist Heat or Steam Sterilization
[00840338601612]
Moist Heat or Steam Sterilization
[00840338601612]
Moist Heat or Steam Sterilization
[00840338601612]
Moist Heat or Steam Sterilization
[00840338601612]
Moist Heat or Steam Sterilization
[00840338601612]
Moist Heat or Steam Sterilization
[00840338601612]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-31 |
| Device Publish Date | 2024-10-23 |
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| 00846832099337 | Peripheral Drill Guide |
| 00846832099320 | Peripheral Drill Guide |
| 00846832099313 | Cortiloc Drill Guide |
| 00846832099306 | Central Drill Guide |
| 00846832099283 | Ascend Flex Inlay Reamer |
| 00846832099276 | Ascend Flex Sizer Disk |
| 00846832099269 | Ascend Flex Inlay Reamer |
| 00846832099252 | Bow Tie Reamer Case |
| 00846832099245 | Perform+ Half Wedge Guide |
| 00846832099238 | Perform+ Half Wedge Guide |
| 00846832099221 | Grooved Trilat |
| 00846832099214 | Aequalis Half Moon Reamer |
| 00846832099207 | Aequalis Half Moon Reamer |
| 00846832099191 | Aequalis Half Moon Reamer |
| 00846832099184 | Aequalis Half Moon Reamer |
| 00846832099177 | Aequalis Half Moon Reamer |
| 00846832099160 | Aequalis Half Moon Reamer |
| 00846832099153 | Aequalis Half Moon |
| 00846832099146 | Aequalis Half Moon |
| 00846832099139 | Aequalis Half Moon |
| 00846832099122 | Aequalis Half Moon |
| 00846832099115 | Aequalis Half Moon |
| 00846832099108 | Aequalis Half Moon |
| 00846832099092 | Sonnabend Retractor No Holes |
| 00846832099061 | Central Drill With Stop |
| 00846832099054 | Central Drill With Stop |
| 00846832099047 | Central Drill With Stop |
| 00846832099030 | Central Drill With Stop |
| 00846832099023 | Simpliciti Core Drill |
| 00846832098996 | Ascend Flex Inserter |
| 00846832098989 | Cuff Spreader |
| 00846832098972 | BIO-RSA Pin Guide |
| 00846832098965 | Ascend Flex Ream And Run |
| 00846832098958 | Starter Awl |
| 00846832098941 | Metal Cement Mold Head |
| 00846832098934 | Metal Cement Mold Head |
| 00846832098927 | Metal Cement Mold Head |
| 00846832098910 | Metal Cement Mold Head |
| 00846832098903 | Metal Cement Mold Stem |
| 00846832098897 | Metal Cement Mold Stem |
| 00846832098880 | Metal Cement Mold Stem |
| 00846832098873 | Metal Cement Mold Stem |
| 00846832098866 | Metal Cement Mold Screw |
| 00846832098859 | Cut Guide Assembly |
| 00846832098842 | Cross Arm Assembly Cut Guide |
| 00846832098835 | Graft Reamer |
| 00846832098828 | Graft Reamer |
| 00846832098811 | Drill Quick Release |
| 00846832098804 | Simpliciti Insertion Guide |