| 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 |
| 10607151000100 - BOVIE | 2025-12-30 BURR 2 |
| 10607151000117 - BOVIE | 2025-12-30 REUSABLE 2.5MM OPHTHALMIC BURR TIP |
| 10607151000124 - BOVIE | 2025-12-30 REUSABLE 5MM OPHTHALMIC BURR TIP |
| 10607151001428 - BOVIE | 2025-12-30 GROUNDING PLATE; REUSABLE |
| 10607151001534 - Bovie | 2025-12-30 REUSABLE GROUNDING PAD WITH CABLE |
| 10607151001541 - BOVIE | 2025-12-30 REUSABLE GROUNDING CABLE |
| 10607151001589 - Bovie | 2025-12-30 UNIVERSAL FOOT CONTROL ADAPTER |
| 10607151002258 - Bovie | 2025-12-30 SURCH-LITE ™ SURGICAL LIGHT 5'' (12.7cm) |