| Primary Device ID | 00850057092653 |
| NIH Device Record Key | 0bcbeff1-1ffb-4be2-b09f-bb658d523a63 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hexa Dentall |
| Version Model Number | HS-4009 |
| Catalog Number | HS-4009 |
| Company DUNS | 096955608 |
| Company Name | Hexa Dental |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850057092653 [Primary] |
| ELW | Material, Impression |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-22 |
| Device Publish Date | 2026-01-14 |
| 00008579280274 - sure Endo | 2026-01-30 Knitted Retraction Cord Impregnated w/Aluminum Chloride #1 - 100 Inch (254cm) Blue |
| 00850079280182 - Sure Endo | 2026-01-30 Knitted Retraction Cord #000 - 100 Inch (254cm) Green |
| 00850079280199 - Sure Endo | 2026-01-30 Knitted Retraction Cord #00 - 100 Inch (254cm) Brown |
| 00850079280205 - Sure endo | 2026-01-30 Knitted Retraction Cord #0 - 100 Inch (254cm) Purple |
| 00850079280212 - Sure Endo | 2026-01-30 Knitted Retraction Cord #1 - 100 Inch (254cm) Blue |
| 00850079280229 - Sure endo | 2026-01-30 Knitted Retraction Cord #2 - 100 Inch (254cm) Orange |
| 00850079280236 - Sure Endo | 2026-01-30 Knitted Retraction Cord Impregnated w/Aluminum Chloride #000.0 - 100 Inch (254cm) Black |
| 00850079280243 - Sure Endo | 2026-01-30 Knitted Retraction Cord Impregnated w/Aluminum Chloride #000 - 100 Inch (254cm) Green |