| Primary Device ID | 00810018096397 |
| NIH Device Record Key | 283018cf-0e74-4458-a0e3-93379ba0eee0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Holymed surgical gowns AAMI Level 4 XL |
| Version Model Number | SIGA412 |
| Company DUNS | 069590113 |
| Company Name | Sol-Millennium Medical, 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 | false |
| OTC Over-The-Counter | false |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com | |
| Phone | 833-637-0857 |
| info@solm.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810018096397 [Primary] |
| GS1 | 00810018096403 [Package] Package: Case [50 Units] In Commercial Distribution |
| FYI | Appliance, Facial Fracture, External |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-18 |
| Device Publish Date | 2025-03-10 |