FDA UDI
In Commercial Distribution
🇺🇸 United States
Dame Ultra Thin
DI: 00813686021715
·
Model: 99DAME202
·
GLOBAL PROTECTION CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
12
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Basic Information
- Brand Name
- Dame Ultra Thin
- Primary DI
- 00813686021715
- Version / Model
- 99DAME202
- Company Name
- GLOBAL PROTECTION CORP.
- Labeler DUNS
- 364614362
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2024-03-18
- Public Version
- 2
- Public Version Date
- 2026-04-24
- Public Version Status
- Update
- Public Device Record Key
- b1da861d-91e2-4325-9f6f-3e644078e2a5
Device Description
Dame Ultra Thin Condoms- 12 count pack- Lubricated latex condoms
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| HIS | Condom | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45138 | Basic male condom, Hevea-latex | A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. 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 | 80813686021711 | GS1 | ||||
| Primary | 00813686021715 | GS1 | ||||
| Package | 20813686021719 | GS1 | Case of 72 | 72 | In Commercial Distribution |
Customer Contacts
- Phone
- 6179462800
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature in a dark, dry place. Avoid excessive heat.