Custom Pack
GUDID 10848340002325
Disposable Equipment Cover
ADVANCE MEDICAL DESIGNS, INC.
Medical equipment drape, single-use| Primary Device ID | 10848340002325 |
| NIH Device Record Key | 5f6f240c-d38e-44b1-9204-0af636bb9978 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Custom Pack |
| Version Model Number | 08-CC163 |
| 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 | 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848340002328 [Primary] |
| GS1 | 10848340002325 [Package] Contains: 00848340002328 Package: [20 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 | true |
| Device Is Sterile | false |
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
[10848340002325]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-23 |
| Device Publish Date | 2024-02-15 |
On-Brand Devices [Custom Pack]
| 10848340002325 | Disposable Equipment Cover |
| 10848340002332 | Disposable Equipment Cover |
| 10848340002417 | Custom Pack |
| 10848340002400 | Custom Pack |
Trademark Results [Custom Pack]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CUSTOM PACK 78667843 not registered Dead/Abandoned |
TRG Accessories, L.L.C. 2005-07-11 |
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