Stimulen 2-200-025
GUDID 00745713995013
1 gram Collagen Powder
Southwest Technologies, Inc.
Collagen wound matrix dressing| Primary Device ID | 00745713995013 |
| NIH Device Record Key | 8d7af65a-c882-4e4f-b4f1-d44aca079342 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stimulen |
| Version Model Number | ST9501 |
| Catalog Number | 2-200-025 |
| Company DUNS | 048078018 |
| Company Name | Southwest Technologies, Inc. |
| Device Count | 10 |
| 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 |
Customer Support Contacts
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com | |
| Phone | +1(800)247-9951 |
| quality@elastogel.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00745713095010 [Unit of Use] |
| GS1 | 00745713695012 [Primary] |
| GS1 | 00745713995013 [Package] Contains: 00745713695012 Package: Case [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030774
FDA Product Code
| KGN | Wound dressing with animal-derived material(s) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-01 |
| Device Publish Date | 2023-02-21 |
On-Brand Devices [Stimulen]
| 00745713095157 | 10 gram Collagen Powder |
| 00745713995013 | 1 gram Collagen Powder |
Trademark Results [Stimulen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STIMULEN 98238250 not registered Live/Pending |
Southwest Technologies, Inc. 2023-10-24 |
 STIMULEN 85811387 4597978 Live/Registered |
Southwest Technologies, Inc. 2012-12-27 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.