Morpheus

GUDID H787065084025

Splittable Sheath Dilator Assembly

ANGIODYNAMICS, INC.

Vascular catheter introduction set, nonimplantable

Primary Device ID	H787065084025
NIH Device Record Key	03c835e4-d085-4769-808f-d9b9eae0d11c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Morpheus
Version Model Number	06508402
Company DUNS	079105071
Company Name	ANGIODYNAMICS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
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	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com
Phone	+1(518)795-1676
Email	dgreer@angiodynamics.com

Device Dimensions

Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French
Catheter Gauge	4 French

Operating and Storage Conditions

Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius
Storage Environment Temperature	Between 0 and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684012133 [Secondary]
HIBCC	H787065084020 [Primary]
HIBCC	H787065084025 [Package] Contains: H787065084020 Package: BOX [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K051655

FDA Product Code

DRC

Trocar

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-06-07
Device Publish Date	2016-09-20

On-Brand Devices [Morpheus]

H787065566065	Micro Introducer Kit
H787065084045	Splittable Sheath Dilator Assembly
H787065084035	Splittable Sheath Dilator Assembly
H787065084025	Splittable Sheath Dilator Assembly
H787065072135	Platinum Tip Guidewire
H787065072125	Platinum Tip Guidewire
H787065072115	Stainless Steel Guidewire
H787065072105	Stainless Steel Guidewire

Trademark Results [Morpheus]

Mark Image Registration \| Serial	Company Trademark Application Date
MORPHEUS 98477191 not registered Live/Pending	Lorient Capital Management, LLC 2024-04-01
MORPHEUS 98477186 not registered Live/Pending	Lorient Capital Management, LLC 2024-04-01
MORPHEUS 98407656 not registered Live/Pending	Prophetic, Inc. 2024-02-15
MORPHEUS 98380689 not registered Live/Pending	EXODUS PUBLISHING COMPANY LLC 2024-01-29
MORPHEUS 97809391 not registered Live/Pending	Empyrean Medical Systems, Inc. 2023-02-23
MORPHEUS 97761955 not registered Live/Pending	MORPHEUS XR, INC. 2023-01-20
MORPHEUS 97678902 not registered Live/Pending	Vudoo Labs, Inc. 2022-11-15
MORPHEUS 97639257 not registered Live/Pending	WILLIAM WOLF BRAND LLC 2022-10-19
MORPHEUS 97618412 not registered Live/Pending	Musculoskeletal Transplant Foundation 2022-10-04
MORPHEUS 97310663 not registered Live/Pending	Empyrean Medical Systems, Inc. 2022-03-14
MORPHEUS 97017056 not registered Live/Pending	ByoWave Ltd. 2021-09-08
MORPHEUS 90785332 not registered Live/Pending	Creative Marketing, Inc. 2021-06-21