FDA UDI
In Commercial Distribution
🇺🇸 United States
Manhood
DI: 05708932286350
·
Model: 27-4200-B / 50710
·
COLOPLAST CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
Basic Information
- Brand Name
- Manhood
- Primary DI
- 05708932286350
- Version / Model
- 27-4200-B / 50710
- Catalog Number
- 27-4200-B / 50710
- Company Name
- COLOPLAST CORP.
- Labeler DUNS
- 847436391
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2020-12-16
- Public Version
- 3
- Public Version Date
- 2023-03-13
- Public Version Status
- Update
- Public Device Record Key
- b6d87578-1d72-4f0a-8124-8ccc6ed9d062
Device Description
Manhood. Absorbent Pouches. Capacity 250 ml.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| EYQ | GARMENT, PROTECTIVE, FOR INCONTINENCE | Gastroenterology, Urology | 876.5920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35817 | Incontinence pants liner | A disposable pad composed of absorbent materials that is worn inside incontinence pants to catch and retain urine from an incontinent person. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05708932286350 | GS1 | ||||
| Package | 05708932286367 | GS1 | Shipper Box | 12 | In Commercial Distribution | |
| Unit of Use | 05708932761758 | GS1 |
Customer Contacts
- Phone
- +1(800)533-0464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Capacity - ml 250 |