AMS 700™ CXR TENACIO™ Pump 72404465

GUDID 00191506021542

Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic

BOSTON SCIENTIFIC CORPORATION

Inflatable penile prosthesis
Primary Device ID00191506021542
NIH Device Record Keycef9fbae-a48d-4127-8f48-3194b8851e9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMS 700™ CXR TENACIO™ Pump
Version Model Number72404465
Catalog Number72404465
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter
Length10 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506021542 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-05
Device Publish Date2024-01-26

On-Brand Devices [AMS 700™ CXR TENACIO™ Pump]

00191506021580Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
00191506021573Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
00191506021566Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
00191506021559Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
00191506021542Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
00191506021535Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal
00191506021528Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal
00191506021511Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal
00191506021504Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal
00191506021498Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal

Trademark Results [AMS 700]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AMS 700
AMS 700
78763908 3282570 Live/Registered
BOSTON SCIENTIFIC SCIMED, INC.
2005-11-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.