Handy Solutions
GUDID 10024291281419
Navajo Manufacturing Company
Basic male condom, Hevea-latex| Primary Device ID | 10024291281419 |
| NIH Device Record Key | 3ca5ebb2-17a4-47bf-9ea3-6b3cb834d868 |
| Commercial Distribution Discontinuation | 2019-10-24 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Handy Solutions |
| Version Model Number | 28141 |
| Company DUNS | 091917799 |
| Company Name | Navajo Manufacturing Company |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 10024291281419 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K033076
FDA Product Code
| HIS | Condom |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-27 |
| Device Publish Date | 2016-08-31 |
On-Brand Devices [Handy Solutions]
Trademark Results [Handy Solutions]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HANDY SOLUTIONS 86195717 4853555 Live/Registered |
Navajo Manufacturing Company 2014-02-17 |
 HANDY SOLUTIONS 75718324 2440062 Live/Registered |
NAVAJO MANUFACTURING CO. 1999-06-01 |
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