EDP EDP-MOS

GUDID 00850004857045

External Penile Rigidity Device Manually Operated

REACH MEDICAL, INC.

Penile vacuum device
Primary Device ID00850004857045
NIH Device Record Key54b12ecb-2c28-4650-b2d8-9005b497191f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDP
Version Model NumberEDP-MOS
Catalog NumberEDP-MOS
Company DUNS127526064
Company NameREACH MEDICAL, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone901-861-6068
Emailinfo@reachmedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004857045 [Primary]

FDA Product Code

LKYDevice, External Penile Rigidity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-08
Device Publish Date2019-12-31

On-Brand Devices [EDP]

00850004857069External Penile Rigidity Device Manual and Battery Operated
00850004857052External Penile Rigidity Device Battery Operated
00850004857045External Penile Rigidity Device Manually Operated
00850004857113Manual Penile Rigidity Device.

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