Heliogen XP-1000

GUDID 00813954026169

Fibrillar Collagen Matrix

COLLAGEN MATRIX, INC.

Collagen wound matrix dressing
Primary Device ID00813954026169
NIH Device Record Keyd045385c-99ec-454d-ba10-e4fb287f3cf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeliogen
Version Model NumberXP-1000
Catalog NumberXP-1000
Company DUNS176262442
Company NameCOLLAGEN MATRIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com
Phone866-477-4219
Emailcustomerservice@mimedx.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954026169 [Primary]

FDA Product Code

KGNWound Dressing With Animal-Derived Material(S)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-04
Device Publish Date2024-05-27

On-Brand Devices [Heliogen]

00813954026176Fibrillar Collagen Matrix
00813954026169Fibrillar Collagen Matrix
00813954026152Fibrillar Collagen Matrix

Trademark Results [Heliogen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HELIOGEN
HELIOGEN
98485513 not registered Live/Pending
MiMedx Group, Inc.
2024-04-05
HELIOGEN
HELIOGEN
98204535 not registered Live/Pending
Heliogen, Inc.
2023-09-29
HELIOGEN
HELIOGEN
98203603 not registered Live/Pending
Heliogen, Inc.
2023-09-29
HELIOGEN
HELIOGEN
90032502 not registered Live/Pending
Heliogen, Inc.
2020-07-02
HELIOGEN
HELIOGEN
88431341 not registered Live/Pending
Edisun Microgrids, Inc.
2019-05-15
HELIOGEN
HELIOGEN
77893056 not registered Dead/Abandoned
Stephen A. Yencho
2009-12-14
HELIOGEN
HELIOGEN
77050239 not registered Dead/Abandoned
Stephen A. Yencho
2006-11-22
HELIOGEN
HELIOGEN
71391004 0349318 Live/Registered
GENERAL DYESTUFF CORPORATION
1937-04-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.