AMS Ambicor
GUDID 00878953000954
Inflatable Penile Prosthesis, Prefilled and Preconnected Cylinder and Pump Component, 8 Extenders (2 each: 0.5, 1, 2, 3 cm), 2 Keith Needles
AMERICAN MEDICAL SYSTEMS, INC.
Inflatable penile prosthesis| Primary Device ID | 00878953000954 |
| NIH Device Record Key | ff9f89db-f2a1-4a06-b05e-32d452fabfba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMS Ambicor |
| Version Model Number | 72401451 |
| Company DUNS | 125111448 |
| Company Name | AMERICAN MEDICAL SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Length | 16 Centimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Lumen/Inner Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
| Outer Diameter | 12.5 Millimeter |
| Length | 16 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00878953000954 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: N970012
FDA Product Code
| FHW | Device, Impotence, Mechanical/Hydraulic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-13 |
| Device Publish Date | 2014-09-24 |
On-Brand Devices [AMS Ambicor ]
| 00878953001029 | Inflatable Penile Prosthesis, Prefilled and Preconnected Cylinder and Pump Component, 8 Extend |
| 00878953001012 | Inflatable Penile Prosthesis, Prefilled and Preconnected Cylinder and Pump Component, 8 Extend |
| 00878953001005 | Inflatable Penile Prosthesis, Prefilled and Preconnected Cylinder and Pump Component, 8 Extend |
| 00878953000992 | Inflatable Penile Prosthesis, Prefilled and Preconnected Cylinder and Pump Component, 8 Extend |
| 00878953000985 | Inflatable Penile Prosthesis, Prefilled and Preconnected Cylinder and Pump Component, 8 Extend |
| 00878953000978 | Inflatable Penile Prosthesis, Prefilled and Preconnected Cylinder and Pump Component, 8 Extend |
| 00878953000961 | Inflatable Penile Prosthesis, Prefilled and Preconnected Cylinder and Pump Component, 8 Extend |
| 00878953000954 | Inflatable Penile Prosthesis, Prefilled and Preconnected Cylinder and Pump Component, 8 Extend |
| 00878953000947 | Inflatable Penile Prosthesis, Prefilled and Preconnected Cylinder and Pump Component, 8 Extend |
Trademark Results [AMS Ambicor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMS AMBICOR 74368958 1912387 Live/Registered |
AMS RESEARCH CORPORATION 1993-03-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.