Premium Rubber Helmet Condoms
GUDID 00850016109019
Premium Rubber Helmet Condoms Aegis 49 Lubricated Latex Condoms - 100 Bulk Count
Scutagli, LLC
Basic male condom, Hevea-latex| Primary Device ID | 00850016109019 |
| NIH Device Record Key | 65243baf-acee-417d-ae7a-fd403e3afe55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Premium Rubber Helmet Condoms |
| Version Model Number | RH10100 |
| Company DUNS | 078668294 |
| Company Name | Scutagli, LLC |
| Device Count | 100 |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com | |
| Phone | 7203515879 |
| emukai@scutagli.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850016109019 [Primary] |
| GS1 | 00850016109026 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K994095
FDA Product Code
| HIS | Condom |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-01 |
| Device Publish Date | 2021-06-23 |
On-Brand Devices [Premium Rubber Helmet Condoms]
| 00850016109019 | Premium Rubber Helmet Condoms Aegis 49 Lubricated Latex Condoms - 100 Bulk Count |
| 00850016109088 | Premium Rubber Helmet Condoms Aegis 49 Lubricated Latex Condoms - 6 Bulk Count |
| 00850016109156 | Premium Rubber Helmet Condoms Aegis 49 Lubricated Latex Condoms - 24 Bulk Count |
| 00850016109712 | Lifestyles Snugger Fit with Premium Rubber Helmet Condoms Silver Pocket Case - 50 Bulk Count |
Trademark Results [Premium Rubber Helmet Condoms]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PREMIUM RUBBER HELMET CONDOMS 88454326 not registered Live/Pending |
Scutagli, LLC 2019-05-31 |
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