| Primary Device ID | 05030267124381 |
| NIH Device Record Key | 4ef7c1ca-6183-4409-9865-a0445be8bcf2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPTILUBE BOX OF 150 SACHETS |
| Version Model Number | 5469000 |
| Company DUNS | 785952607 |
| Company Name | Intersurgical Incorporated |
| 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 | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05030267118113 [Primary] |
| GS1 | 05030267120765 [Package] Contains: 05030267118113 Package: [600 Units] In Commercial Distribution |
| GS1 | 05030267124381 [Package] Contains: 05030267118113 Package: [150 Units] In Commercial Distribution |
| KMJ | Lubricant, Patient |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-23 |
| Device Publish Date | 2023-06-15 |
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