| Primary Device ID | 20887761000685 |
| NIH Device Record Key | f3631807-b807-456f-8ade-7425cfab837a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ASO EU® Wound Closure |
| Version Model Number | 40-2893 |
| Company DUNS | 027680821 |
| Company Name | ASPEN SURGICAL PRODUCTS, 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 | true |
| Manufacturing Date | false |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887761000681 [Primary] |
| GS1 | 10887761000688 [Package] Contains: 00887761000681 Package: [50 Units] In Commercial Distribution |
| GS1 | 20887761000685 [Package] Contains: 10887761000688 Package: [4 Units] In Commercial Distribution |
| FPX | Strip, adhesive, closure, skin |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-18 |
| Device Publish Date | 2018-12-13 |
| 10840113232830 - Skytron Lumos | 2024-06-14 Disposable rigid handle for Lumos series lights |
| 10840113232847 - Skytron Lumos | 2024-06-14 Disposable camera cover for Lumos series lights |
| 00840113231485 - Amnihook Amniotic Membrane Perforator | 2023-03-07 Stork AmniHook, Amniotic Membrane Perforator, Yellow, Sterile, 1/pouch, 100pouches/box |
| 00840113231508 - Double-Grip Umbilical Cord Clamp | 2023-03-07 Double Grip Umbilical Cord Clamps – Sterile |
| 00840113231539 - PlastiBell Circumcision Device | 2023-03-07 PlastiBell Circumcision Device, Hospital Bulk Pack |
| 00840113231546 - PlastiBell Circumcision Device | 2023-03-07 1.1 cm PlastiBell Circumcision Device |
| 00840113231560 - PlastiBell Circumcision Device | 2023-03-07 1.2 cm PlastiBell Circumcision Device |
| 00840113231577 - PlastiBell Circumcision Device | 2023-03-07 1.3 cm PlastiBell Circumcision Device |