| Primary Device ID | 00854804007129 |
| NIH Device Record Key | 11bb7cbf-9084-4e98-b7ee-ef01048de6b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SurgiPlast Nasal Splint |
| Version Model Number | SurgiPlast - Large - Skin Color - 1.6mm |
| Company DUNS | 080380106 |
| Company Name | SURGICAL TECHNOLOGY LABORATORIES 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854804007129 [Primary] |
| EPP | Splint, Nasal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-08 |
| Device Publish Date | 2024-09-30 |
| 00854804007242 | SurgiPlast - Square - White Color - 2.0mm |
| 00854804007235 | SurgiPlast - Square - White Color - 1.6mm |
| 00854804007228 | SurgiPlast - Square - Skin Color - 2.0mm |
| 00854804007211 | SurgiPlast - Square - Skin Color - 1.6mm |
| 00854804007204 | SurgiPlast - Small - White Color - 2.0mm |
| 00854804007198 | SurgiPlast - Small - White Color - 1.6mm |
| 00854804007174 | SurgiPlast - Small - Skin Color - 2.0mm |
| 00854804007167 | SurgiPlast - Small - Skin Color - 1.6mm |
| 00854804007150 | SurgiPlast - Large - White Color - 2.0mm |
| 00854804007143 | SurgiPlast - Large - White Color - 1.6mm |
| 00854804007136 | SurgiPlast - Large - Skin Color - 2.0mm |
| 00854804007129 | SurgiPlast - Large - Skin Color - 1.6mm |