FDA UDI
In Commercial Distribution
🇺🇸 United States
AMS 800 Artificial Urinary Sphincter
DI: 00878953003153
·
Model: 72404137
·
BOSTON SCIENTIFIC CORPORATION
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
- 00878953003153
- Version / Model
- 72404137
- Catalog Number
- 72404137
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 9
- Public Version Date
- 2025-10-16
- Public Version Status
- Update
- Public Device Record Key
- 915171be-2d80-49ef-b547-ff004ecbcea6
Device Description
Occlusive Cuff with InhibiZone
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00878953003153 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P000053 | 005 |
| P000053 | 041 |
| P000053 | 047 |
| P000053 | 050 |
| P000053 | 053 |
| P000053 | 054 |
| P000053 | 065 |
| P000053 | 067 |
| P000053 | 075 |
| P000053 | 083 |
| P000053 | 095 |
| P000053 | 096 |
| P000053 | 103 |
| P000053 | 104 |
| P000053 | 105 |
| P000053 | 112 |
| P000053 | 137 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7.5 | Centimeter |