| Primary Device ID | 00867469000206 |
| NIH Device Record Key | 32f021bc-02b6-4098-9d0b-a5ab76609103 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SubQ It! |
| Version Model Number | 404010 |
| Company DUNS | 965571289 |
| Company Name | OPUS KSD, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| 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 |
| Phone | +1 339 933 8811 |
| chuck@subq-it.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00867469000206 [Primary] |
| GS1 | 10867469000203 [Package] Package: Shelf Box [10 Units] In Commercial Distribution |
| GDW | Staple, Implantable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-08-06 |
| Device Publish Date | 2016-08-30 |
| 00867469000206 | SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, disposable stapler |
| 10867469000210 | SubQ It! Bioabsorbable Skin Closure SF10 is a single-patient use, skin stapler preloaded with 10 |