FDA UDI
In Commercial Distribution
🇺🇸 United States
SKYN
DI: 08859798107307
·
Model: 18859798107304
·
SURETEX LIMITED - BRANCH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
40
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Basic Information
- Brand Name
- SKYN
- Primary DI
- 08859798107307
- Version / Model
- 18859798107304
- Company Name
- SURETEX LIMITED - BRANCH
- Labeler DUNS
- 672044515
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 40
- Record Status
- Published
- Publish Date
- 2025-09-04
- Public Version
- 1
- Public Version Date
- 2025-09-12
- Public Version Status
- New
- Public Device Record Key
- c5e34002-57b6-4031-a152-0870c26963b1
Device Description
SKYN Original Non-Latex Condom BX40
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| MOL | Condom, Synthetic | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34151 | Basic male condom, synthetic polymer | A sheath made from synthetic polymers (e.g., polyurethane, polyisoprene) 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 | 28859798106496 | GS1 | ||||
| Primary | 08859798107307 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171172 | 000 |