FDA UDI
In Commercial Distribution
🇺🇸 United States
Vacurect
DI: 00861753000217
·
Model: Deluxe 1002
·
MAINSPRING MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vacurect
- Primary DI
- 00861753000217
- Version / Model
- Deluxe 1002
- Company Name
- MAINSPRING MEDICAL, LLC
- Labeler DUNS
- 133686100
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- baa32541-cff9-4e06-afc5-6670f0c1fdd6
Device Description
Vacurect vacuum erection device with 10 tension systems, 4 oz personal lubricant, 4 oz flavored lubricant, 2 oz service oil, travel bag, user's guide, and lifetime warranty.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LKY | Device, External Penile Rigidity | Gastroenterology, Urology | 876.5020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17744 | Penile vacuum device | A device that is applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is typically a two-component device consisting of: 1) a manually-operated, vacuum pump/sleeve which is applied over the flaccid penis and used to create a vacuum to achieve tumescence through an up and down movement along a vacuum tube; and 2) a constriction ring used in conjunction with the pump and placed upon the penis to maintain the erection. The ring remains on the penis for a recommended period of time. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00861753000217 | GS1 |