FDA UDI
Not in Commercial Distribution
🇺🇸 United States
m. Dior
DI: 00692563400122
·
Model: 53±2mm
·
Suzhou Colourway New Material Co., Ltd.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- m. Dior
- Primary DI
- 00692563400122
- Version / Model
- 53±2mm
- Company Name
- Suzhou Colourway New Material Co., Ltd.
- Labeler DUNS
- 544612070
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-27
- Public Version
- 1
- Public Version Date
- 2025-04-04
- Public Version Status
- New
- Public Device Record Key
- 5f245cfd-abfd-4db7-9733-c9791cc77102
- Distribution End Date
- 2025-03-28
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 | 00692563400122 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083817 | 000 |