| Primary Device ID | 27466532979325 |
| NIH Device Record Key | 89c2bb81-e1a3-45cd-bc10-4b1f3694c2dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rampart |
| Version Model Number | M1128-CDK |
| Catalog Number | M1128-CDK |
| Company DUNS | 817435655 |
| Company Name | DAS Medical International SRL |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com | |
| Phone | 1 809-556-8900 |
| lrondon@ufpt.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07466532979321 [Primary] |
| GS1 | 27466532979325 [Package] Contains: 07466532979321 Package: Case [15 Units] In Commercial Distribution |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
[27466532979325]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-02 |
| Device Publish Date | 2025-04-24 |
| 17466532979229 | Rampart OUS Drape Kit |
| 17467423230528 | Rampart M1130 Drape (M1130- CDK) |
| 27466532979325 | RAMPART M1128 DRAPE KIT (M1128-CDK) |