FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ONE Pleasure Dome
DI: 20726893111183
·
Model: 11200C
·
GLOBAL PROTECTION CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ONE Pleasure Dome
- Primary DI
- 20726893111183
- Version / Model
- 11200C
- Company Name
- GLOBAL PROTECTION CORP.
- Labeler DUNS
- 364614362
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-08
- Public Version
- 2
- Public Version Date
- 2023-11-07
- Public Version Status
- Update
- Public Device Record Key
- 447822a8-4b4c-4d6b-b024-ce9416d97ff9
- Distribution End Date
- 2023-11-06
Device Description
Lubricated male latex condom. Please ignore this entry as it is a duplicated one with incorrect DI number. Please refer the DI number 20726893111831 for the correct product information.
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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 20726893111183 | GS1 |