FDA UDI
In Commercial Distribution
🇺🇸 United States
Premium Condom Samplers
DI: 00726893112872
·
Model: BSC01096
·
GLOBAL PROTECTION CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
96
Basic Information
- Brand Name
- Premium Condom Samplers
- Primary DI
- 00726893112872
- Version / Model
- BSC01096
- Company Name
- GLOBAL PROTECTION CORP.
- Labeler DUNS
- 364614362
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 96
- Record Status
- Published
- Publish Date
- 2023-12-07
- Public Version
- 1
- Public Version Date
- 2023-12-15
- Public Version Status
- New
- Public Device Record Key
- cc6e1026-8ab6-4bad-8243-36440ee43574
Device Description
Premium Condom samplers 96 ct. List of condoms in the bag: One Flavor Waves, Lifestyles Tuxedo (A6200C), One Vanish, Crown (LC21C), One Flex, L.A.Confidential (Love Triangle) Studded (CW1000LAC), Trojan Enz, One Ultra Feel, Lifestyles SKYN Original (A7800C), My One 51F, My One 53F, My One 53 G,
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 | 80726893112878 | GS1 | ||||
| Primary | 00726893112872 | GS1 |
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.