Probe Cover
GUDID 10848340013093
Probe Cover
ADVANCE MEDICAL DESIGNS, INC.
Medical equipment drape, single-use| Primary Device ID | 10848340013093 |
| NIH Device Record Key | d582c86d-7390-4144-9d8e-6793dee2f2bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Probe Cover |
| Version Model Number | 27-GF200 |
| 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 | 00848340013096 [Primary] |
| GS1 | 10848340013093 [Package] Contains: 00848340013096 Package: [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K011265
FDA Product Code
| ITX | Transducer, ultrasonic, diagnostic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10848340013093]
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Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-02 |
| Device Publish Date | 2024-03-25 |
On-Brand Devices [Probe Cover]
| 10848340008686 | Prove Cover |
| 10848340013093 | Probe Cover |
Trademark Results [Probe Cover]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROBE COVER 97750202 not registered Live/Pending |
Zhou, Haiting 2023-01-11 |
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