FDA UDI
In Commercial Distribution
🇺🇸 United States
SKYN
DI: 00070907001073
·
Model: 0107
·
SURETEX LIMITED - BRANCH
Product Codes
2
GMDN Terms
2
Identifiers
4
Pkg Device Count
13
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Basic Information
- Brand Name
- SKYN
- Primary DI
- 00070907001073
- Version / Model
- 0107
- Company Name
- SURETEX LIMITED - BRANCH
- Labeler DUNS
- 672044515
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 13
- Record Status
- Published
- Publish Date
- 2023-06-26
- Public Version
- 1
- Public Version Date
- 2023-07-04
- Public Version Status
- New
- Public Device Record Key
- c9544020-4b84-475c-baa6-ccda3ce9ebce
Device Description
SKYN ORIGINAL 12CT + 1 NATURALLY ENDLESS SACHET
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
| NUC | Lubricant, Personal | 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 |
| 60412 | Sexual lubricant | A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00070907001073 | GS1 | ||||
| Unit of Use | 80070907102165 | GS1 | ||||
| Package | 10070907001070 | GS1 | BUNDLE | 4 | In Commercial Distribution | |
| Package | 30070907001074 | GS1 | CASE | 24 | In Commercial Distribution |
Customer Contacts
- Phone
- 848-229-3224
- [email protected]