EKCOMED EKM-PPR0634

GUDID 00850000965133

Perineal Post Roll

EKCOMED, LLC

Limb/torso/head restraint, single-use
Primary Device ID00850000965133
NIH Device Record Keye31d9f5b-b3d1-4dbf-8b1f-581c23b778a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEKCOMED
Version Model NumberEKM-PPR0634
Catalog NumberEKM-PPR0634
Company DUNS178249053
Company NameEKCOMED, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com
Phone800-517-1833
Emailinfo@ekcomed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850000965133 [Primary]

FDA Product Code

CCXSupport, Patient Position

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-04
Device Publish Date2022-10-27

On-Brand Devices [EKCOMED]

00850000965133Perineal Post Roll
00850000965126SAN Shoulder Suspension Kit
00850000965119Universal Head Positioner
00850000965102Ankle Distraction Kit
00850000965096V-Critter Face Mask
00850000965089Shoulder Suspension sleeve V Kit
00850000965072McPull Shoulder Kit
00850000965065DKP Knee Kit
00850000965058TBC Shoulder Kit
00850000965041Shoulder Suspension Sleeve Kit
00850000965034Critter Stabilization Device
00850000965027Critter Face Mask
00850000965010SUREtriever Suture Retriever
00850000965003Shoulder Suspension Kit

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.