| Primary Device ID | 10871321001284 |
| NIH Device Record Key | daba63f2-662d-498d-ac68-611b344dc8ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 5.0mm Round Sponge |
| Version Model Number | S 1982-5-M |
| Company DUNS | 248911026 |
| Company Name | Labtician Ophthalmics, Inc |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | 00871321000129 [Unit of Use] |
| GS1 | 10871321001284 [Primary] |
| HQJ | Implant, Absorbable, (Scleral Buckling Methods) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-01-27 |
| Device Publish Date | 2018-02-22 |
| 18713210001284 | 5.0mm Round Sponge |
| 10871321001284 | 5.0mm Round Sponge |