AMS Ambicor RTE Kit

GUDID 00878953001364

Rear Tip Extenders 8 (2 each: 0.5, 1, 2, 3 cm)

AMERICAN MEDICAL SYSTEMS, INC.

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Primary Device ID	00878953001364
NIH Device Record Key	96486944-b818-4585-86fd-f1b8ba251946
Commercial Distribution Status	In Commercial Distribution
Brand Name	AMS Ambicor RTE Kit
Version Model Number	72402890
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	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter
Length	3 Centimeter
Length	2 Centimeter
Length	1 Centimeter
Length	0.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953001364 [Primary]

FDA Product Code

FHW	Device, Impotence, Mechanical/Hydraulic

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

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