AMS 800 Artificial Urinary Sphincter
- Primary DI
- 00878953000718
- Brand
- AMS 800 Artificial Urinary Sphincter
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- 72400160
- Catalog number
- 72400160
- Device description
- Occlusive Cuff
- Published
- 2014-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| EZY | Device, Incontinence, Mechanical/Hydraulic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| EZY | Device, Incontinence, Mechanical/Hydraulic | Gastroenterology, Urology | 3 |
Premarket Submissions#
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| P000053 | 000 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 003 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 004 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 047 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 050 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 065 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 067 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 075 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 083 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 095 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 096 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 100 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 101 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 105 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 112 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
| P000053 | 137 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | Boston Scientific Corp | 2001-06-14 | EZY |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00878953000718 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00878953000718 | 00878953000718 | 878953000718 | 0878953000718 |
GMDN Terms#
| Term | Definition |
|---|---|
| Urethral sphincter prosthesis system | A sterile implantable assembly of devices indicated for incontinence and intended to support or replace a natural urethral sphincter. It is a hydraulically-operated system typically consisting of a single or double cuff to surround the urethra, a reservoir for the hydraulic liquid, e.g., saline with/without radiopacifier, and a manually driven pump. It is made of a non-bioabsorbable polymeric material. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Length | 4 | Centimeter |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 021717889
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
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|---|---|---|---|---|
| 00685447020677 | RFP-100A™ RF Puncture Generator | M004RFP100A0 | M004RFP100A0 | 2026-06-08 |
| 00191506049232 | Orbera™ | M00505670 | M00505670 | 2026-06-04 |
| 08714729121190 | Ultraflex™ Esophageal NG | M00514200 | 2015-09-24 | |
| 08714729121206 | Ultraflex™ Esophageal NG | M00514210 | 2015-09-24 | |
| 08714729121213 | Ultraflex™ Esophageal NG | M00514220 | 2015-09-24 | |
| 08714729121220 | Ultraflex™ Esophageal NG | M00514230 | 2015-09-24 | |
| 08714729649113 | Ultraflex™ Esophageal NG | M00513750 | 2015-09-24 | |
| 08714729716075 | Ultraflex™ Esophageal NG | M00513850 | 2015-09-24 | |
| 08714729716082 | Ultraflex™ Esophageal NG | M00513860 | 2015-09-24 | |
| 08714729716099 | Ultraflex™ Esophageal NG | M00513840 | 2015-09-24 | |
| 08714729716105 | Ultraflex™ Esophageal NG | M00514240 | 2015-09-24 | |
| 08714729716112 | Ultraflex™ Esophageal NG | M00514250 | 2015-09-24 | |
| 08714729716129 | Ultraflex™ Esophageal NG | M00513700 | 2015-09-24 | |
| 08714729716136 | Ultraflex™ Esophageal NG | M00513710 | 2015-09-24 | |
| 08714729716143 | Ultraflex™ Esophageal NG | M00513720 | 2015-09-24 | |
| 08714729716150 | Ultraflex™ Esophageal NG | M00513730 | 2015-09-24 | |
| 08714729716167 | Ultraflex™ Esophageal NG | M00513740 | 2015-09-24 | |
| 08714729716174 | Ultraflex™ Esophageal NG | M00513800 | 2015-09-24 | |
| 08714729716181 | Ultraflex™ Esophageal NG | M00513810 | 2015-09-24 | |
| 08714729716198 | Ultraflex™ Esophageal NG | M00513820 | 2015-09-24 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00878953000602 | AMS 800 Artificial Urinary Sphincter | AMERICAN MEDICAL SYSTEMS, INC. | EZY | 2014-09-24 |
| 00878953000619 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000626 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000633 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000640 | AMS 800 Artificial Urinary Sphincter | AMERICAN MEDICAL SYSTEMS, INC. | EZY | 2014-09-24 |
| 00878953000657 | AMS 800 Artificial Urinary Sphincter | AMERICAN MEDICAL SYSTEMS, INC. | EZY | 2014-09-24 |
| 00878953000688 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000725 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000732 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000749 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000756 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000763 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000770 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000787 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000794 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000800 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000817 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953000824 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953001036 | AMS 800 Artificial Urinary Sphincter | AMERICAN MEDICAL SYSTEMS, INC. | EZY | 2014-09-24 |
| 00878953003078 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953003085 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953003092 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953003108 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953003115 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953003122 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953003139 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953003146 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953003153 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953003160 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |
| 00878953003177 | AMS 800 Artificial Urinary Sphincter | BOSTON SCIENTIFIC CORPORATION | EZY | 2014-09-24 |