MEDIHONEY® Hydrogel DUP31740

GUDID 30381780471428

(ADHESIVE) HYDROGEL SHEET with LEPTOSPERMUM HONEY

ACELL, INC.

Wound-nonadherent dressing, permeable, antimicrobial
Primary Device ID30381780471428
NIH Device Record Key8349e55b-c8af-4215-84d1-9f0a3014b38f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDIHONEY® Hydrogel
Version Model Number31740
Catalog NumberDUP31740
Company DUNS137258252
Company NameACELL, 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com
Phone+1(800)826-2926
Emailcustomerservice@acell.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780471424 [Primary]
GS130381780471428 [Package]
Contains: 10381780471424
Package: Case [5 Units]
In Commercial Distribution

FDA Product Code

FRODressing, wound, drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-06-08
Device Publish Date2018-10-23

Devices Manufactured by ACELL, INC.

00386190002056 - MicroMatrix®2023-10-10 MicroMatrix® Flex 5cc
30381780471398 - MEDIHONEY® HCS2023-06-08 (ADHESIVE) HYDROGEL COLLOIDAL SHEET with LEPTOSPERMUM HONEY
30381780471428 - MEDIHONEY® Hydrogel2023-06-08(ADHESIVE) HYDROGEL SHEET with LEPTOSPERMUM HONEY
30381780471428 - MEDIHONEY® Hydrogel2023-06-08 (ADHESIVE) HYDROGEL SHEET with LEPTOSPERMUM HONEY
30381780471367 - MediHoney®2023-05-12 (NON-ADHESIVE) HYDROGEL COLLOIDAL SHEET with LEPTOSPERMUM HONEY
30381780486972 - MediHoney®2023-05-11 MEDIHONEY® Gel Dressing with Active Leptospermum Honey Wound and Burn Dressing
00386190002681 - Gentrix®2020-08-31 Surgical Matrix Thick 16 x 20 cm
00386190002698 - Gentrix®2020-08-31 Surgical Matrix Thick 10 x 20 cm
00386190002063 - Cardion™2020-08-21 for Pericardial Repair, 7 x 15 cm

Trademark Results [MEDIHONEY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MEDIHONEY
MEDIHONEY
85984150 5003695 Live/Registered
Comvita Limited
2012-11-20
MEDIHONEY
MEDIHONEY
85982592 4676106 Live/Registered
Comvita Limited
2012-11-20
MEDIHONEY
MEDIHONEY
85783645 not registered Dead/Abandoned
Comvita Limited
2012-11-20
MEDIHONEY
MEDIHONEY
75846487 2694376 Live/Registered
DERMA SCIENCES, INC.
1999-11-11

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