AMS 700 Spherical Reservoir

GUDID 00878953003207

Spherical Reservoir with InhibiZone

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis
Primary Device ID00878953003207
NIH Device Record Key3bf3518f-6630-47b0-b8f4-b518ddccb5c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMS 700 Spherical Reservoir
Version Model Number72404155
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 Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter
Total Volume65 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100878953003207 [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 Number4
Public Version Date2019-02-13
Device Publish Date2014-09-24

On-Brand Devices [AMS 700 Spherical Reservoir ]

00878953003245Spherical Reservoir
00878953003238Spherical Reservoir
00878953003214Spherical Reservoir with InhibiZone
00878953003207Spherical Reservoir with InhibiZone
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