FDA UDI
In Commercial Distribution
🇺🇸 United States
Genesis
DI: 05708932324748
·
Model: 91-9511SC
·
Coloplast A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Genesis
- Primary DI
- 05708932324748
- Version / Model
- 91-9511SC
- Catalog Number
- 91-9511SC
- Company Name
- Coloplast A/S
- Labeler DUNS
- 305524696
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-28
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 2aab0596-b065-4aa9-bf19-64f89d443ced
Device Description
Malleable Penile Prosthesis
Device Characteristics
- Single Use
- Yes
- 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
- MR Conditional
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FAE | PROSTHESIS, PENILE | Gastroenterology, Urology | 876.3630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36251 | Rigid penile prosthesis | A rigid or semi-rigid sterile rod or cylinder-like device intended to be surgically implanted in the corpora cavernosa of the penis in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve permanent penile tumescence and rigidity adequate for vaginal intercourse. This device is available in a variety of designs and materials such as: 1) a flexible solid rod of polymer; 2) a flexible polymer or silicone cylinder with an internal silver (Ag) coil core; or 3) a single- or multiple-hinged rod enabling the user to position the penis downwards for better concealment under clothing. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05708932324748 | GS1 |
Customer Contacts
- Phone
- +1(800)258-3476
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040959 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 11 | Millimeter | |
| Device Size Text, specify | Device Length is 16-25 centimeters |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of sunlight