FDA UDI
In Commercial Distribution
🇺🇸 United States
Satin Dams
DI: 00726893114913
·
Model: LGDMXU
·
GLOBAL PROTECTION CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Satin Dams
- Primary DI
- 00726893114913
- Version / Model
- LGDMXU
- Company Name
- GLOBAL PROTECTION CORP.
- Labeler DUNS
- 364614362
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-07-07
- Public Version
- 1
- Public Version Date
- 2023-07-17
- Public Version Status
- New
- Public Device Record Key
- a43327b2-f619-4ecb-a5ee-25c620daa5f2
Device Description
Latex Prophylactic Oral Dams
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MSC | Barrier, Std, Oral Sex | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47729 | Oral/vaginal sex barrier, Hevea-latex | A device in the form of a flat sheet (a rubber dam), composed of Hevea-latex, designed to help reduce the risk of catching/spreading sexually transmitted infections (STI), also known as sexually transmitted diseases (STD), such as syphilis, gonorrhoea, Chlamydia infections, genital herpes, and acquired immune deficiency syndrome (AIDS ) during oral-vaginal sexual activity. It is placed over the entire vulva, covering both the vaginal opening and the clitoris, or alternatively, over the entire anal area, including the anus. It is held in place by one of the sexual partners and may be moistened with a commercially available lubricant to enhance performance. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 80726893114919 | GS1 | ||||
| Primary | 00726893114913 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990067 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.