Custom Cover
GUDID 10848340020305
Non-sterile
ADVANCE MEDICAL DESIGNS, INC.
Medical equipment drape, single-use| Primary Device ID | 10848340020305 |
| NIH Device Record Key | 9bfa33f2-667c-4e9f-8520-4acb8763d0a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Custom Cover |
| Version Model Number | 08-CC152 |
| Company DUNS | 130785884 |
| Company Name | ADVANCE MEDICAL DESIGNS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848340020308 [Primary] |
| GS1 | 10848340020305 [Package] Contains: 00848340020308 Package: [400 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K850959
FDA Product Code
| JAA | System, x-ray, fluoroscopic, image-intensified |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-20 |
| Device Publish Date | 2024-03-12 |
On-Brand Devices [Custom Cover]
| 10848340009904 | Disposable Equipment Cover |
| 10848340005906 | Disposable Equipment Cover |
| 10848340008747 | Disposable Equipment Cover |
| 10848340005913 | Disposable Equipment Cover |
| 10848340005524 | Non-Sterile |
| 10848340002226 | Disposable Equipment Cover |
| 10848340002240 | Disposable Equipment Cover |
| 10848340002233 | Auto. Pull Back Device |
| 10848340020114 | Disposable Equipment Cover |
| 10848340002264 | Disposable Equipment Cover |
| 10848340002257 | w/Closed End |
| 10848340005487 | Non-sterile |
| 10848340005470 | Non-Sterile |
| 10848340020305 | Non-sterile |
| 10848340005500 | Non-sterile |
Trademark Results [Custom Cover]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CUSTOM COVER 75702925 2454539 Dead/Cancelled |
Penda Corporation 1999-05-12 |
 CUSTOM COVER 73686927 not registered Dead/Abandoned |
KNOPP, DON 1987-09-28 |
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