| Primary Device ID | 20845854045753 | 
| NIH Device Record Key | eff611aa-72ab-4574-99f6-1745bcfa2ea8 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SPECTRUM AUTOPASS | 
| Version Model Number | SMI-02N | 
| Catalog Number | SMI-02N | 
| Company DUNS | 071595540 | 
| Company Name | Conmed Corporation | 
| Device Count | 5 | 
| 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 | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| 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(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 | 
| CustomerExperience@conmed.com | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00845854045759 [Unit of Use] | 
| GS1 | 10845854045756 [Primary] | 
| GS1 | 20845854045753 [Package] Contains: 10845854045756 Package: CARTON [5 Units] In Commercial Distribution | 
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2024-08-12 | 
| Device Publish Date | 2021-05-30 | 
| 10845854042243 | SPECTRUM AUTOPASS SUTURE PASSER | 
| 20845854045753 | SPECTRUM AUTOPASS SUTURE PASSER NEEDLE |