AMS 700 Spherical Reservoir

GUDID 00878953003214

Spherical Reservoir with InhibiZone

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis

Primary Device ID	00878953003214
NIH Device Record Key	58bec693-1a20-4924-996a-573da7998574
Commercial Distribution Status	In Commercial Distribution
Brand Name	AMS 700 Spherical Reservoir
Version Model Number	72404156
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	false
Device Combination Product	true
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

Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter
Total Volume	100 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953003214 [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 Spherical Reservoir ]

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

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