ORDOCK PLATFORM, RE-USABLE 14100

GUDID B992141000

PLATFORM (RE-USABLE) TO WHICH 2 ORDOCK CUPS (Not INCLUDED) ARE ATTACHED TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE, NEEDS TO BE STERILIZED PRIOR TO USE (SEE INSTRUCTIONS FOR AUTOCLAVE)

JB Medical Development, LLC

Surgical instrument containment holder, reusable

Primary Device ID	B992141000
NIH Device Record Key	578d6d02-333b-458d-9b47-a45372ccb0eb
Commercial Distribution Status	In Commercial Distribution
Brand Name	ORDOCK PLATFORM, RE-USABLE
Version Model Number	14-100
Catalog Number	14100
Company DUNS	873149871
Company Name	JB Medical Development, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com
Phone	8776036333
Email	hsjeck@md3inc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B992141000 [Primary]

FDA Product Code

LXH	Orthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

[B992141000]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-02-16
Device Publish Date	2021-02-08

Devices Manufactured by JB Medical Development, LLC

B99214101010 - ORDOCK CUP, DISPOSABLE	2022-01-26 A SINGLE, STERILE CUP THAT ATTACHES TO A PLATFORM (NOT INCLUDED) TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE. THIS CUP IS SO
B992151000 - PREFERX DELIVERY SYSTEM, DISPOSABLE	2021-10-07 THE PREFERX DELIVERY SYSTEM IS INTENDED TO BE USED FOR THE DELIVERY OF HYDRATED ALLOGRAFT, AUTOGRAFT, OR SYNTHETIC BONE GRAFT MA
B992101000 - BIO-SAV BONE MILL, DISPOSABLE	2021-05-18 DISPOSABLE, MANUALLY OPERATED BONE MILL THAT SAVES TIME, PRODUCES A BETTER AUTO GRAFT PASTE, AND ELIMINATES CLEANING/STERILIZING
B992141000 - ORDOCK PLATFORM, RE-USABLE	2021-02-16PLATFORM (RE-USABLE) TO WHICH 2 ORDOCK CUPS (Not INCLUDED) ARE ATTACHED TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE, NEEDS TO BE STERILIZED PRIOR TO USE (SEE INSTRUCTIONS FOR AUTOCLAVE)
B992141000 - ORDOCK PLATFORM, RE-USABLE	2021-02-16 PLATFORM (RE-USABLE) TO WHICH 2 ORDOCK CUPS (Not INCLUDED) ARE ATTACHED TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE, NEEDS T
B992141010 - ORDOCK 2 CUPS, DISPOSABLE	2021-02-16 2 STERILE CUPS THAT ATTACH TO A PLATFORM (NOT INCLUDED) TO HOLD INSTRUMENTS DURING A SURGICAL PROCEDURE

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