AMS 700 CXR RTE Kit

GUDID 00878953002408

Rear Tip Extender Kit 2 Each: 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 3.0 cm

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis

Primary Device ID	00878953002408
NIH Device Record Key	f5a3e839-8e04-498b-b1c5-9b985a94b633
Commercial Distribution Status	In Commercial Distribution
Brand Name	AMS 700 CXR RTE Kit
Version Model Number	72403872
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	0.5 Centimeter
Length	0.5 Centimeter
Length	0.5 Centimeter
Length	0.5 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1.5 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953002408 [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	4
Public Version Date	2019-02-13
Device Publish Date	2014-09-24

On-Brand Devices [AMS 700 CXR RTE Kit]

00878953002774	Rear Tip Extender Kit, 2 Each 4.0 cm, 5.0 cm, 6.0 cm
00878953002408	Rear Tip Extender Kit 2 Each: 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 3.0 cm