Primary Device ID | 10848340005463 |
NIH Device Record Key | 6563cc9f-faeb-4916-856e-b304b06ab275 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Custom C-Arm Cover |
Version Model Number | 08-CC130 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00848340005466 [Primary] |
GS1 | 10848340005463 [Package] Contains: 00848340005466 Package: [100 Units] In Commercial Distribution |
JAA | System, x-ray, fluoroscopic, image-intensified |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-02-15 |
Device Publish Date | 2024-02-07 |
10848340010481 - Mitaka Drape | 2024-04-25 Disposable Equipment Cover |
10848340011464 - Mitaka Spy Elite | 2024-04-25 Disposable Equipment Cover |
10848340015530 - Rolled Probe Cover | 2024-04-24 Disposable Equipment Cover |
10848340016834 - Rolled Probe Cover | 2024-04-24 Disposable Equipment Cover |
10848340016858 - Rolled Probe Cover | 2024-04-24 Disposable Equipment Cover |
10848340015547 - Rolled Probe Cover | 2024-04-23 Disposable Equipment Cover |
10848340012089 - Sterile Elastic Bands | 2024-04-22 Sterile Elastic Bands |
10848340015486 - C-Arm Pack | 2024-04-22 Disposable Equipment Cover |