Closing Tool

GUDID 00878953000701

Closing Tool

AMERICAN MEDICAL SYSTEMS, INC.

Surgical instrument guard, reusable
Primary Device ID00878953000701
NIH Device Record Key6b9c94a1-dc1f-4bec-91f0-8291eee9e7b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameClosing Tool
Version Model Number72400155
Company DUNS125111448
Company NameAMERICAN MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100878953000480 [Direct Marking]
GS100878953000701 [Primary]

FDA Product Code

JCWProsthesis, Penis, Inflatable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00878953000701]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-13
Device Publish Date2014-09-24

Devices Manufactured by AMERICAN MEDICAL SYSTEMS, INC.

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