Halsted Health

GUDID 00860006105099

Silicone Male External Catheter. Self-Adhering. Non-Sterile.

Flex Source International, Inc.

Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use, non-sterile Urinary incontinence penis sheath/port, single-use Urinary incontinence penis sheath/port, single-use Urinary incontinence penis sheath/port, single-use Urinary incontinence penis sheath/port, single-use Urinary incontinence penis sheath/port, single-use Urinary incontinence penis sheath/port, single-use Urinary incontinence penis sheath/port, single-use
Primary Device ID00860006105099
NIH Device Record Key205546d2-91b7-4b49-987f-617b8f3594e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHalsted Health
Version Model NumberSize 32MM - # 7732-30
Company DUNS097915269
Company NameFlex Source International, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com
Phone858-539-6246
Emailinfo@halstedhealth.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860006105075 [Primary]
GS100860006105099 [Package]
Contains: 00860006105075
Package: [30 Units]
In Commercial Distribution

FDA Product Code

NNXDevice, Incontinence, Urosheath Type, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-24
Device Publish Date2022-01-14

On-Brand Devices [Halsted Health]

00860006105020Syringes with needle
00860006105068Syringes with needle
00860006105099Silicone Male External Catheter. Self-Adhering. Non-Sterile.
00860006105051Silicone Male External Catheter. Self-Adhering. Non-Sterile.
00860010400227BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE

Trademark Results [Halsted Health]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HALSTED HEALTH
HALSTED HEALTH
88740641 not registered Live/Pending
Flex Source International, Inc.
2019-12-27
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