EKCOMED EKM-SSS1606V

GUDID 00850000965089

Shoulder Suspension sleeve V Kit

EKCOMED, LLC

Limb/torso/head restraint, single-use
Primary Device ID00850000965089
NIH Device Record Key0e7e1d65-68e8-4f0f-81e8-ffe030e11687
Commercial Distribution StatusIn Commercial Distribution
Brand NameEKCOMED
Version Model NumberEKM-SSS1606V
Catalog NumberEKM-SSS1606V
Company DUNS178249053
Company NameEKCOMED, LLC
Device Count10
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
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
GS100850000965089 [Primary]
GS110850000965086 [Unit of Use]

FDA Product Code

KDDKit, Surgical Instrument, Disposable

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00850000965089]

Ethylene Oxide

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[00850000965089]

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[00850000965089]

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[00850000965089]

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[00850000965089]

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[00850000965089]

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[00850000965089]

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[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

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[00850000965089]

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[00850000965089]

Ethylene Oxide

[00850000965089]

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[00850000965089]

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[00850000965089]

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[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

Ethylene Oxide

[00850000965089]

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[00850000965089]

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Ethylene Oxide

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
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