FDA UDI
In Commercial Distribution
🇺🇸 United States
PRUDENCE MIX C/12
DI: 00812420030259
·
Model: Condom
·
DKT de México, S.A. de C.V.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- PRUDENCE MIX C/12
- Primary DI
- 00812420030259
- Version / Model
- Condom
- Company Name
- DKT de México, S.A. de C.V.
- Labeler DUNS
- 814851960
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-21
- Public Version
- 1
- Public Version Date
- 2020-01-29
- Public Version Status
- New
- Public Device Record Key
- 6474eb9f-8185-4cec-9c67-0d0322208195
Device Description
Contraceptive, condom, male 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."
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00812420030259 | GS1 | ||||
| Package | 00812420030204 | GS1 | Inner | 12 | In Commercial Distribution | |
| Package | 10812420030201 | GS1 | Inner | 6 | In Commercial Distribution | |
| Package | 20812420030208 | GS1 | Case | 24 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K041837 | 000 |