| Primary Device ID | 00083208130014 |
| NIH Device Record Key | ac637abf-498c-433e-8b2b-47777d8705d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Seldin retractor |
| Version Model Number | Seldin |
| Catalog Number | Seldin |
| Company DUNS | 078352849 |
| Company Name | Suncoast Dental, 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 | 727-536-4880 |
| tatumcompliance@gmail.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00083208130014 [Primary] |
| EIG | Retractor, All Types |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00083208130014]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-22 |
| Device Publish Date | 2020-04-14 |
| 00083208130014 | Seldin retractor used to retract and protect soft tissue, to give better visualization and acce |
| 00083208132032 | Seldin retractor used to retract and protect soft tissue, to give better visualization and acce |
| 00083208132025 | Seldin retractor used to retract and protect soft tissue, to give better visualization and acce |