FDA UDI
In Commercial Distribution
🇺🇸 United States
Spectra
DI: 00878953005232
·
Model: 720056-01
·
AMERICAN MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Spectra
- Primary DI
- 00878953005232
- Version / Model
- 720056-01
- Company Name
- AMERICAN MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 125111448
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-08-12
- Public Version
- 4
- Public Version Date
- 2019-02-13
- Public Version Status
- Update
- Public Device Record Key
- 3ae52e4c-253d-44f7-b082-27e5a94f8e7c
Device Description
Concealable Penile Prosthesis, 2 Cylinders
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
- Yes
- 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 | 00878953005232 | GS1 | ||||
| Unit of Use | 00878953008950 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 12 | Centimeter | |
| Outer Diameter | 14 | Millimeter |