Conceal

GUDID 00878953005669

Low Profile Reservoir with InhibiZone

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis
Primary Device ID00878953005669
NIH Device Record Key9d56f846-a565-4773-8670-55b359140985
Commercial Distribution StatusIn Commercial Distribution
Brand NameConceal
Version Model Number720185-01
Company DUNS125111448
Company NameAMERICAN MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
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Total Volume100 Milliliter
Total Volume100 Milliliter
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Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter
Total Volume100 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100878953005669 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JCWProsthesis, Penis, Inflatable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-13
Device Publish Date2014-09-25

On-Brand Devices [Conceal]

00878953005676Low Profile Reservoir
00878953005669Low Profile Reservoir with InhibiZone

Trademark Results [Conceal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CONCEAL
CONCEAL
97801096 not registered Live/Pending
Westlake Royal Building Products (USA) Inc.
2023-02-18
CONCEAL
CONCEAL
97335405 not registered Live/Pending
NetAbstraction, Inc.
2022-03-29
CONCEAL
CONCEAL
97299582 not registered Live/Pending
Milliken & Company
2022-03-07
CONCEAL
CONCEAL
90269185 not registered Live/Pending
Royal Building Products (USA) Inc.
2020-10-21
CONCEAL
CONCEAL
88650256 not registered Live/Pending
Feeney, Inc.
2019-10-10
CONCEAL
CONCEAL
88620096 not registered Live/Pending
Balco, Inc.
2019-09-17
CONCEAL
CONCEAL
88320750 not registered Live/Pending
Kohler Co.
2019-02-28
CONCEAL
CONCEAL
88268003 not registered Live/Pending
Beauty 21 Cosmetics, Inc.
2019-01-18
CONCEAL
CONCEAL
87675543 not registered Dead/Abandoned
Michael Full
2017-11-07
CONCEAL
CONCEAL
87429836 not registered Live/Pending
Whitetail Institute of North America, LLC
2017-04-28
CONCEAL
CONCEAL
87397534 not registered Live/Pending
First Quality Retail Services, LLC
2017-04-04
CONCEAL
CONCEAL
87289296 5734347 Live/Registered
Precision Planting LLC
2017-01-04

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