FDA UDI
Not in Commercial Distribution
🇺🇸 United States
AMS 800 Artificial Urinary Sphincter
DI: 00878953000640
·
Model: 72400026
·
AMERICAN MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AMS 800 Artificial Urinary Sphincter
- Primary DI
- 00878953000640
- Version / Model
- 72400026
- Company Name
- AMERICAN MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 125111448
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 6
- Public Version Date
- 2023-08-16
- Public Version Status
- Update
- Public Device Record Key
- 440a3861-125d-44e6-9030-a64cd8e82d7d
- Distribution End Date
- 2016-02-29
Device Description
Pressure Regulating Balloon, Pressure: 81-90 cm H20
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 |
|---|---|---|---|---|
| EZY | Device, Incontinence, Mechanical/Hydraulic | Gastroenterology, Urology | 876.5280 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35280 | Urethral sphincter prosthesis, non-powered | An implantable assembly of non-electric devices intended to support or replace a natural urethral sphincter for the management of incontinence. It is a hydraulically-operated system typically consisting of a cuff to surround the urethra, a reservoir for the hydraulic liquid (e.g., saline with/without radiopacifier), and a manually driven pump. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00878953000640 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 90 | Centimeter |