FDA UDI
In Commercial Distribution
🇺🇸 United States
SKYN
DI: 00070907202074
·
Model: 0207
·
SURETEX LIMITED - BRANCH
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
12
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Basic Information
- Brand Name
- SKYN
- Primary DI
- 00070907202074
- Version / Model
- 0207
- Company Name
- SURETEX LIMITED - BRANCH
- Labeler DUNS
- 672044515
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2019-08-29
- Public Version
- 1
- Public Version Date
- 2019-09-06
- Public Version Status
- New
- Public Device Record Key
- 3b7cc9fd-fb1e-42cc-8d99-c9580e5c1d86
Device Description
SKYN SELECTION 12CT (CONTAINS SKYN ORIGINAL, SKYN EXTRA STUDDED, SKYN ELITE EXTRA LUBE, SKYN ELITE)
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 |
|---|---|---|---|---|---|---|
| Package | 30070907202075 | GS1 | CASE | 6 | In Commercial Distribution | |
| Package | 10070907202071 | GS1 | INNER | 4 | In Commercial Distribution | |
| Primary | 00070907202074 | GS1 | ||||
| Unit of Use | 80070907695667 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160399 | 000 |