| Primary Device ID | 10386040006255 |
| NIH Device Record Key | 286a8bd4-ec0a-4e78-bb47-e3d6b8c309fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COE SYRINGE |
| Version Model Number | 159041 |
| Catalog Number | 159041 |
| Company DUNS | 005473608 |
| Company Name | Gc America 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(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10386040006255 [Primary] |
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-15 |
| Device Publish Date | 2022-07-07 |
| 10386040013512 | SPEC UAB COE SYRINGE W/2 MIXPADS 6X6 |
| 10386040006279 | COE SYRINGE washer and screw |
| 10386040006255 | COE SYRINGE plunger with Washer |
| 10386040006248 | COE SYRINGE hub |
| 10386040006224 | COE SYRINGE barrel |
| 10386040006217 | COE SYRINGE, 12 plastic tips, brush |
| D6581590911 | SPEC UAB COE SYRINGE W/2 MIXPADS 6X6 |