I-STOP TOMS

GUDID 03760151650239

Sling for male incontinence

CL MEDICAL

Stress urinary incontinence surgical mesh, male
Primary Device ID03760151650239
NIH Device Record Key47fe7997-a56a-4aca-ac90-c09f2177a53d
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-STOP TOMS
Version Model NumberIS-TOMS-1
Company DUNS262825552
Company NameCL MEDICAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone718-570-2237
Emailcontact@clmedical.com
Phone718-570-2237
Emailcontact@clmedical.com
Phone718-570-2237
Emailcontact@clmedical.com
Phone718-570-2237
Emailcontact@clmedical.com
Phone718-570-2237
Emailcontact@clmedical.com
Phone718-570-2237
Emailcontact@clmedical.com
Phone718-570-2237
Emailcontact@clmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103760151650239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OTMMesh, Surgical, For Stress Urinary Incontinence, Male

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-04-23
Device Publish Date2017-05-19

Devices Manufactured by CL MEDICAL

03760151650048 - I-STOP2019-04-23 Sling for female incontinence
03760151650055 - I-STOP2019-04-23 Sling for female incontinence
03760151650093 - I-STOP2019-04-23 Sling for female incontinence
03760151650185 - I-STOP2019-04-23 Sling for female incontinence
03760151650239 - I-STOP TOMS2019-04-23Sling for male incontinence
03760151650239 - I-STOP TOMS2019-04-23 Sling for male incontinence
03760151650338 - I-STOP2019-04-23 Sling for female incontinence

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