FDA UDI
In Commercial Distribution
🇺🇸 United States
SKORE (Colors)
DI: 08906007134835
·
Model: SKORE Orange
·
TTK HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- SKORE (Colors)
- Primary DI
- 08906007134835
- Version / Model
- SKORE Orange
- Company Name
- TTK HEALTHCARE LIMITED
- Labeler DUNS
- 675476406
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-27
- Public Version
- 1
- Public Version Date
- 2023-07-05
- Public Version Status
- New
- Public Device Record Key
- a3d779de-8a9c-49ea-ad27-3839c3de643b
Device Description
The SKORE (Colors) is made of natural rubber latex. It is smooth, straight walled, teat ended, orange colored male condoms. It meets the requirements as specified in ISO 4074:2015 – Natural rubber latex male condoms – Requirements and test methods and ASTM D3492:2016– Standard Specification for Rubber Contraceptives (Male Condoms). The SKORE(Colors) natural rubber latex condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
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 |
|---|---|---|---|---|---|---|
| Package | 08906007134842 | GS1 | Wallet | 3 | In Commercial Distribution | |
| Primary | 08906007134835 | GS1 | ||||
| Package | 08906007134859 | GS1 | Carton | 240 | In Commercial Distribution | |
| Package | 08906007134866 | GS1 | Case | 2160 | In Commercial Distribution |
Customer Contacts
- Phone
- +914442008231
- [email protected]
- Phone
- +914442008234
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202403 | 000 |