FDA UDI
In Commercial Distribution
🇺🇸 United States
AMS Ambicor
DI: 00878953000992
·
Model: 72401455
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AMS Ambicor
- Primary DI
- 00878953000992
- Version / Model
- 72401455
- Catalog Number
- 72401455
- 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
- 8
- Public Version Date
- 2024-10-22
- Public Version Status
- Update
- Public Device Record Key
- dbdaba34-1a27-42da-a4a3-16f921b8432f
Device Description
Inflatable Penile Prosthesis
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology | 876.3350 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36250 | Inflatable penile prosthesis | An inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is available in a variety of designs and materials and typically consists of: 1) one or two inflatable cylinders implanted into the corpora cavernosa of the penis; 2) a subcutaneous manual pump bulb implanted into the scrotum; 3) a reservoir containing fluid (e.g., saline with/without radiopacifier) implanted in the abdomen; and 4) kink-resistant tubing that connect the component parts. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00878953000992 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| N970012 | 000 |
| N970012 | 094 |
| N970012 | 096 |
| N970012 | 110 |
| N970012 | 118 |
| N970012 | 121 |
| N970012 | 145 |
| N970012 | 151 |
| N970012 | 157 |
| N970012 | 158 |
| N970012 | 161 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 14 | Millimeter | |
| Length | 20 | Centimeter |