FDA UDI
In Commercial Distribution
🇺🇸 United States
SKORE BULBOUS DOTS AND RIBS
DI: 08906007131711
·
Model: BULBOUS DOTS AND RIBS
·
TTK HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
3
Basic Information
- Brand Name
- SKORE BULBOUS DOTS AND RIBS
- Primary DI
- 08906007131711
- Version / Model
- BULBOUS DOTS AND RIBS
- Company Name
- TTK HEALTHCARE LIMITED
- Labeler DUNS
- 675476406
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-10-03
- Public Version
- 4
- Public Version Date
- 2018-08-15
- Public Version Status
- Update
- Public Device Record Key
- 274bc67d-5932-45a3-9dde-988bff825170
Device Description
The SKORE Bulbous Dots & Ribs Natural is made of natural rubber latex.It is a bulbous teat ended, fully textured, transparent male condom. It meets the requirements as specified in ASTM D 3492 standard for rubber latex contraceptives (Male condoms). The Skore bulbous dots and ribs 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 | 08906007131735 | GS1 | 2160 | In Commercial Distribution | ||
| Package | 08906007131728 | GS1 | 240 | In Commercial Distribution | ||
| Primary | 08906007131711 | GS1 | ||||
| Unit of Use | 08906007131827 | GS1 |
Customer Contacts
- Phone
- +914442008200
- [email protected]
- Phone
- +914442008231
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132490 | 000 |