Sterion® Skin Closure
GUDID 10887761000831
Intended for skin closure and closure support for sutures and staples
ASPEN SURGICAL PRODUCTS, INC.
Skin-closure adhesive strip| Primary Device ID | 10887761000831 |
| NIH Device Record Key | 7e7ff50b-d160-4937-8582-57d101429718 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sterion® Skin Closure |
| Version Model Number | 753048PBX |
| Company DUNS | 027680821 |
| Company Name | ASPEN SURGICAL PRODUCTS, INC. |
| Device Count | 2 |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887761000834 [Primary] |
| GS1 | 10887761000831 [Package] Contains: 00887761000834 Package: [25 Units] In Commercial Distribution |
| GS1 | 80887761000830 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K874813
FDA Product Code
| FPX | Strip, adhesive, closure, skin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-18 |
| Device Publish Date | 2019-05-31 |
On-Brand Devices [Sterion® Skin Closure]
| 10887761000664 | Intended for skin closure and closure support for sutures and staples |
| 10887761000671 | Intended for skin closure and closure support for sutures and staples |
| 10887761000763 | Intended for skin closure and closure support for sutures and staples |
| 10887761000756 | Intended for skin closure and closure support for sutures and staples |
| 10887761000749 | Intended for skin closure and closure support for sutures and staples |
| 10887761000732 | Intended for skin closure and closure support for sutures and staples |
| 10887761000725 | Intended for skin closure and closure support for sutures and staples |
| 10887761000718 | Intended for skin closure and closure support for sutures and staples |
| 10887761000701 | Intended for skin closure and closure support for sutures and staples |
| 10887761000695 | Intended for skin closure and closure support for sutures and staples |
| 10887761000787 | Intended for skin closure and closure support for sutures and staples |
| 10887761000770 | Intended for skin closure and closure support for sutures and staples |
| 20887761000531 | Intended for skin closure and closure support for sutures and staples |
| 10887761000831 | Intended for skin closure and closure support for sutures and staples |
| 10887761000824 | Intended for skin closure and closure support for sutures and staples |
| 10887761000817 | Intended for skin closure and closure support for sutures and staples |
| 10887761000800 | Intended for skin closure and closure support for sutures and staples |
| 10887761000794 | Intended for skin closure and closure support for sutures and staples |
| 10887761000657 | Intended for skin closure and closure support for sutures and staples |
| 10887761000640 | Intended for skin closure and closure support for sutures and staples |
| 10887761000633 | Intended for skin closure and closure support for sutures and staples |
| 10887761000626 | Intended for skin closure and closure support for sutures and staples |
| 10887761000619 | Intended for skin closure and closure support for sutures and staples |
| 10887761000602 | Intended for skin closure and closure support for sutures and staples |
| 20887761000593 | Intended for skin closure and closure support for sutures and staples |
| 10887761000589 | Intended for skin closure and closure support for sutures and staples |
| 10887761000572 | Intended for skin closure and closure support for sutures and staples |
| 00840113225842 | Intended for skin closure and closure support for sutures and staples |
| 00840113225828 | Intended for skin closure and closure support for sutures and staples |
| 00840113225804 | Intended for skin closure and closure support for sutures and staples |
| 00840113225774 | Intended for skin closure and closure support for sutures and staples |
| 00840113225750 | Intended for skin closure and closure support for sutures and staples |
| 00840113225712 | Intended for skin closure and closure support for sutures and staples |
| 00840113225705 | Intended for skin closure and closure support for sutures and staples |
| 10840113225672 | Intended for skin closure and closure support for sutures and staples |
| 00840113225644 | Intended for skin closure and closure support for sutures and staples |
| 00840113225637 | Intended for skin closure and closure support for sutures and staples |
| 00840113225590 | Intended for skin closure and closure support for sutures and staples |
| 00840113225576 | Intended for skin closure and closure support for sutures and staples |
| 00840113225569 | Intended for skin closure and closure support for sutures and staples |
| 00840113225545 | Intended for skin closure and closure support for sutures and staples |
| 10840113225511 | Intended for skin closure and closure support for sutures and staples |
| 00840113225484 | Intended for skin closure and closure support for sutures and staples |
| 00840113225446 | Intended for skin closure and closure support for sutures and staples |
| 00840113225422 | Intended for skin closure and closure support for sutures and staples |
| 00840113225408 | Intended for skin closure and closure support for sutures and staples |
| 00840113225385 | Intended for skin closure and closure support for sutures and staples |
| 00840113225361 | Intended for skin closure and closure support for sutures and staples |
| 00840113225347 | Intended for skin closure and closure support for sutures and staples |
| 00840113225316 | Intended for skin closure and closure support for sutures and staples |
Trademark Results [Sterion]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERION 85657512 4479685 Live/Registered |
Aspen Surgical Products, Inc. 2012-06-21 |
 STERION 74382150 1842831 Dead/Cancelled |
JOHNSON & JOHNSON 1993-04-26 |
 STERION 73806220 1585477 Dead/Cancelled |
JOHNSON & JOHNSON 1989-06-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.