FDA.reportPublic FDA data

AMS 700

Primary DI
00878953002439
Brand
AMS 700
Company
AMERICAN MEDICAL SYSTEMS, INC.
Model
72403900
Device description
Tactile Pump with InhibiZone
Published
2014-09-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JCWProsthesis, Penis, Inflatable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCWProsthesis, Penis, InflatableGastroenterology, Urology3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00878953002439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878953002439008789530024398789530024390878953002439

GMDN Terms#

Term, Definition table
TermDefinition
Inflatable penile prosthesisAn inflatable/deflatable sterile device designed of several interconnected components intended to be surgically implanted in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve selective penile tumescence and rigidity adequate for vaginal intercourse. It is available in a variety of designs and materials and typically consists of: 1) one or two inflatable cylinders implanted into the corpora cavernosa of the penis; 2) a subcutaneous manual pump bulb implanted into the scrotum; 3) a reservoir containing fluid (e.g., saline with/without radiopacifier) implanted in the abdomen; and 4) kink-resistant tubing that connect the component parts.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125111448
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00878953005249Spectra 720056-022016-08-12
00878953005201Spectra 720054-012016-08-12
00878953005218Spectra 720054-022016-08-12
00878953005225Spectra 720054-032016-08-12
00878953005232Spectra 720056-012016-08-12
00878953005256Spectra 720056-032016-08-12
00878953005270Spectra 720074-012016-08-12
00878953005287Spectra 720074-022016-08-12
00878953005294Spectra 720074-032016-08-12
00878953005393Spectra RTE Kit720170-012016-08-12
00878953005409Spectra RTE Kit720171-012016-08-12
00878953003023Proximal Tool724041202014-09-24
00878953000602AMS 800 Artificial Urinary Sphincter724000222014-09-24
00878953000640AMS 800 Artificial Urinary Sphincter724000262014-09-24
00878953000657AMS 800 Artificial Urinary Sphincter724000272014-09-24
00878953005881AdVance 844143792016-07-22
00878953005898AdVance 10083802016-07-22
00878953005300AdVance 720088-012016-07-22
00878953000497Sizer720153-012016-09-24
00878953000503Sizer720153-012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506021214AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021221AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021238AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021245AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021252AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021269AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021276AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021283AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021290AMS 700™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021306AMS 700™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021313AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021320AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021337AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021344AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021351AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021368AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021375AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021382AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021399AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021405AMS 700™ CX TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021412AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021429AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021436AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021443AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021450AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021467AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021474AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021481AMS 700 LGX™ TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021498AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26
00191506021504AMS 700™ CXR TENACIO™ PumpBOSTON SCIENTIFIC CORPORATIONJCW2024-01-26