| Primary Device ID | 00810101311147 |
| NIH Device Record Key | d1471da4-ca96-4514-909c-14866a06d780 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DinamicOR |
| Version Model Number | 111-2112d |
| Company DUNS | 018250858 |
| Company Name | Paneffort, LLC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com | |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com | |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com | |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com | |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com | |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com | |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com | |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com | |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com | |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com | |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com | |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com | |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com | |
| Phone | 585-433-8080 |
| customerservice@dinamicor.com |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00810101311147 [Primary] |
| GS1 | 10810101311144 [Package] Package: Case [12 Units] In Commercial Distribution |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-20 |
| Device Publish Date | 2025-06-12 |
| 10810101311113 | DinamicOR Procedure Fee with Double-Wide Sterile Table Cover 12/case |
| 10810101310369 | DinamicOR Procedure Fee with Triple-Wide Sterile Table Cover 10/case |
| 10810101311151 | DinamicOR Procedure Fee with Triple-Wide Sterile Table Cover 10/case |
| 00810101311147 | DinamicOR Procedure Fee with Double-Wide Sterile Table Cover 12/case |