FDA UDI
In Commercial Distribution
🇺🇸 United States
Sustain Natural Extra Large Ribs and Dots.
DI: 08906007132084
·
Model: Sustain Natural Extra Large Ribs and Dots
·
TTK HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
9
Pkg Device Count
1
Basic Information
- Brand Name
- Sustain Natural Extra Large Ribs and Dots.
- Primary DI
- 08906007132084
- Version / Model
- Sustain Natural Extra Large Ribs and Dots
- Company Name
- TTK HEALTHCARE LIMITED
- Labeler DUNS
- 675476406
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-10
- Public Version
- 3
- Public Version Date
- 2018-08-15
- Public Version Status
- Update
- Public Device Record Key
- 3a2b9806-c4b1-458e-80d1-40d9662566e6
Device Description
The Sustain Natural Extra large Ribs and Dots 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 D3492 standard for rubber latex contraceptives (Male Condoms). The Sustain Natural Extra large Ribs and Dots 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 | 08906007132152 | GS1 | Box | 144 | In Commercial Distribution | |
| Primary | 08906007132084 | GS1 | ||||
| Package | 08906007132121 | GS1 | Box | 10 | In Commercial Distribution | |
| Package | 08906007132091 | GS1 | Box | 3 | In Commercial Distribution | |
| Package | 08906007132107 | GS1 | Case | 18 | In Commercial Distribution | |
| Package | 08906007132169 | GS1 | Carton | 1152 | In Commercial Distribution | |
| Package | 08906007132138 | GS1 | Case | 60 | In Commercial Distribution | |
| Package | 08906007132145 | GS1 | Carton | 480 | In Commercial Distribution | |
| Package | 08906007132114 | GS1 | Carton | 144 | In Commercial Distribution |
Customer Contacts
- Phone
- +914442008231
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132490 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store condoms in a cool, dry place ( below 100deg.F). Avoid exposure to direct sunlight.