FDA UDI
Not in Commercial Distribution
🇺🇸 United States
C3
DI: 08519520073347
·
Model: Male Continence Device
·
PERSONAL MEDICAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- C3
- Primary DI
- 08519520073347
- Version / Model
- Male Continence Device
- Catalog Number
- 910300
- Company Name
- PERSONAL MEDICAL CORP.
- Labeler DUNS
- 078511333
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-27
- Public Version
- 3
- Public Version Date
- 2025-12-31
- Public Version Status
- Update
- Public Device Record Key
- 632763eb-8105-46b0-96bb-86a675c400ca
- Distribution End Date
- 2025-12-31
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FHA | Clamp, Penile | Gastroenterology, Urology | 876.5160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37882 | Incontinence penis clamp, single-use | A male urinary incontinence device designed to gently compress the penis, either the proximal shaft or the glans penis, to occlude the urethra and prevent involuntary urination/dribbling for men who are incontinent of the bladder. It is typically made of plastic materials and is designed as an adjustable, two hinged, self-retaining lever clamp with foam rubber inserts; the user can typically adjust the tension to suit their penis size and needs. It is removed by the user when voiding and then reapplied. This is a single-use device which is discarded when soiled. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08519520073347 | GS1 |
Customer Contacts
- Phone
- 425-242-6373
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Large | ||
| Device Size Text, specify | Medium | ||
| Device Size Text, specify | Small |