EDP EDP-MOS100

GUDID 00850004857113

Manual Penile Rigidity Device.

REACH MEDICAL, INC.

Penile vacuum device
Primary Device ID00850004857113
NIH Device Record Key0b093d71-e957-4f6f-862d-44f4f4988e50
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDP
Version Model NumberEDP-MOS100
Catalog NumberEDP-MOS100
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004857113 [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 Date2024-01-26
Device Publish Date2024-01-18

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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