Conceal
GUDID 00878953005669
Low Profile Reservoir with InhibiZone
AMERICAN MEDICAL SYSTEMS, INC.
Inflatable penile prosthesis| Primary Device ID | 00878953005669 |
| NIH Device Record Key | 9d56f846-a565-4773-8670-55b359140985 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Conceal |
| Version Model Number | 720185-01 |
| 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 | false |
| Device Combination Product | true |
| 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
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00878953005669 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: N970012
FDA Product Code
| JCW | Prosthesis, Penis, Inflatable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-02-13 |
| Device Publish Date | 2014-09-25 |
On-Brand Devices [Conceal]
| 00878953005676 | Low Profile Reservoir |
| 00878953005669 | Low Profile Reservoir with InhibiZone |
Trademark Results [Conceal]
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