Sizer

Primary DI
00878953000497
Brand
Sizer
Company
AMERICAN MEDICAL SYSTEMS, INC.
Model
720153-01
Device description
Cylinder Sizing Tool
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FAEProsthesis, Penile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAEProsthesis, PenileGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00878953000497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878953000497008789530004978789530004970878953000497

GMDN Terms#

Term, Definition table
TermDefinition
Medical ruler, reusableA small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws). It is not dedicated to wound measurements. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter9.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
125111448
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
00878953000503Sizer720153-012016-09-24
00878953001036AMS 800 Artificial Urinary Sphincter724016852014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850299008443RIGI10 Rigicon, Inc.FAE2024-01-26
00850299008450RIGI10Rigicon, Inc.FAE2024-01-26
00850299008467RIGI10 Rigicon, Inc.FAE2024-01-26
00850299008474RIGI10Rigicon, Inc.FAE2024-01-26
00850299008481RIGI10 Rigicon, Inc.FAE2024-01-26
00850299008009RIGI10™Rigicon, Inc.FAE2019-12-12
00850299008016RIGI10™Rigicon, Inc.FAE2019-12-12
00850299008023RIGI10™Rigicon, Inc.FAE2019-12-12
00850299008030RIGI10™Rigicon, Inc.FAE2019-12-12
00850299008047RIGI10™Rigicon, Inc.FAE2019-12-12
08714729979340TACTRABOSTON SCIENTIFIC CORPORATIONFAE2019-05-06
08714729979357TACTRABOSTON SCIENTIFIC CORPORATIONFAE2019-05-06
08714729979364TACTRABOSTON SCIENTIFIC CORPORATIONFAE2019-05-06
00878953000503SizerAMERICAN MEDICAL SYSTEMS, INC.FAE2016-09-24
00878953004044Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004051Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004068Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004075Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004082Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004099Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004105Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953004112Rear Tip ExtenderBOSTON SCIENTIFIC CORPORATIONFAE2016-08-12
00878953005201Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12
00878953005218Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12
00878953005225Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12
00878953005232Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12
00878953005249Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12
00878953005256Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12
00878953005270Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12
00878953005287Spectra AMERICAN MEDICAL SYSTEMS, INC.FAE2016-08-12