| Primary Device ID | 10848340017640 |
| NIH Device Record Key | 8c666367-74cc-4c55-a736-c8ee1c325665 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Leap Med |
| Version Model Number | 28-TPU167 |
| Company DUNS | 130785884 |
| Company Name | ADVANCE MEDICAL DESIGNS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848340017643 [Primary] |
| GS1 | 10848340017640 [Package] Contains: 00848340017643 Package: [10 Units] In Commercial Distribution |
| GDF | GUIDE, NEEDLE, SURGICAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
[10848340017640]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-10 |
| Device Publish Date | 2024-04-02 |
| 10848340018418 | Disposable Needle Guide |
| 10848340017961 | Disposable Needle Guide |
| 10848340013130 | Disposable Needle Guide |
| 10848340018425 | Disposable Needle Guide |
| 10848340017817 | Disposable Needle Guide Kit |
| 10848340017770 | Disposable Needle Guide Kit |
| 10848340019835 | Disposable Needle Guide |
| 10848340018395 | Disposable Needle Guide |
| 10848340017831 | Disposable Needle Guide |
| 10848340017640 | Disposable Needle Guide Kit |
| 10848340016995 | Disposable Needle Guide |
| 10848340016988 | Disposable Needle Guide |
| 10848340017275 | Disposable Needle Guide |
| 10848340017008 | Disposable Needle Guide |