Primary Device ID | 00878953000503 |
NIH Device Record Key | 56639507-79b0-4b7e-bbe4-270264f3f0bc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sizer |
Version Model Number | 720153-01 |
Company DUNS | 125111448 |
Company Name | AMERICAN MEDICAL SYSTEMS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Outer Diameter | 12 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00878953000503 [Primary] |
FAE | Prosthesis, Penile |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00878953000503]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 7 |
Public Version Date | 2019-05-07 |
Device Publish Date | 2016-09-24 |
00878953005386 | 1 Sizer 9.5 mm Diameter (00878953000497), 1 Sizer 12 mm Diameter (00878953000503) |
00878953000503 | Cylinder Sizing Tool |
00878953000497 | Cylinder Sizing Tool |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SIZER 97276009 not registered Live/Pending |
Geissler Companies, LLC 2022-02-20 |
![]() SIZER 86311187 4848149 Live/Registered |
CJC Worldwide Technologies, LLC 2014-06-16 |
![]() SIZER 85745807 4342413 Live/Registered |
Plant Food Systems, Inc. 2012-10-04 |
![]() SIZER 78026832 not registered Dead/Abandoned |
MySizer.com 2000-09-20 |
![]() SIZER 74618763 1988061 Dead/Cancelled |
GE HEALTHCARE BIO-SCIENCES AB 1994-12-16 |