EDP MAXRC EDP-MAXRC

GUDID 00850004857106

Rechargeable Penile Rigidity Device.

REACH MEDICAL, INC.

Penile vacuum device
Primary Device ID00850004857106
NIH Device Record Key87d8ae8c-e2d3-48e4-b2fd-d3d0de8cc695
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDP MAXRC
Version Model NumberEDP-MAXRC
Catalog NumberEDP-MAXRC
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
GS100850004857106 [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 Date2024-01-05
Device Publish Date2023-12-28

Devices Manufactured by REACH MEDICAL, INC.

00850004857113 - EDP 2024-01-26 Manual Penile Rigidity Device.
00850004857106 - EDP MAXRC2024-01-05Rechargeable Penile Rigidity Device.
00850004857106 - EDP MAXRC2024-01-05 Rechargeable Penile Rigidity Device.
00850004857045 - EDP2020-01-08 External Penile Rigidity Device Manually Operated
00850004857052 - EDP2020-01-08 External Penile Rigidity Device Battery Operated
00850004857069 - EDP2020-01-08 External Penile Rigidity Device Manual and Battery Operated
00850004857007 - Penile Adjustable Loop2019-03-08 Adjustable penile constriction band that can be used with or without a vacuum erection device.

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