Satin Dams
GUDID 80726893115107
Latex Prophylactic Oral Dam
GLOBAL PROTECTION CORP.
Oral/vaginal sex barrier, Hevea-latex| Primary Device ID | 80726893115107 |
| NIH Device Record Key | 30ec297a-6bee-45dc-bfd4-badcbcbb3729 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Satin Dams |
| Version Model Number | LGPMX12E |
| Company DUNS | 364614362 |
| Company Name | GLOBAL PROTECTION CORP. |
| Device Count | 12 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Keep in a cool, dry place. Protect latex dams against prolonged exposure to moisture, extreme heat (over 104F), direct sunlight and fluorescent light. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00726893115101 [Primary] |
| GS1 | 80726893115107 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K990067
FDA Product Code
| MSC | Barrier, Std, Oral Sex |
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 | 2023-07-17 |
| Device Publish Date | 2023-07-07 |
On-Brand Devices [Satin Dams]
| 80726893115107 | Latex Prophylactic Oral Dam |
| 80726893114919 | Latex Prophylactic Oral Dams |
Trademark Results [Satin Dams]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SATIN DAMS 87455958 5562044 Live/Registered |
Global Protection Corp. 2017-05-18 |
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