FDA.reportPublic FDA data

MediHoney®

Primary DI
00809958036006
Brand
MediHoney®
Company
ACELL, INC.
Model
31844
Catalog number
31844
Device description
MEDIHONEY® Gel Dressing with Active Leptospermum Honey Wound and Burn Dressing
Published
2018-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150985000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150985000Medihoney Wound GelDerma Sciences, Inc.2015-11-19FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00809958036006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00809958036006008099580360068099580360060809958036006

GMDN Terms#

Term, Definition table
TermDefinition
Medical-honey liquid barrier dressing, non-sterileA non-sterile material formed from medical grade honey intended to protect wounds or tissue surfaces by providing a non-occlusive external barrier to bacteria and the environment. It also helps to maintain a moist internal environment for wounds to assist the healing process. The material may be liquid or semi-liquid and is typically applied directly to the wound or tissue surface (e.g., ocular surface). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com
+1(800)826-2926customerservice@acell.com

Regulatory Flags#

DUNS number
137258252
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780486893MEDIHONEY®31840318402019-03-07
10381780486824MediHoney®31515315152018-08-30
10381780486831MediHoney®31535315352018-08-28
10381780486886MediHoney®31815318152018-08-30
10381780486930MediHoney®31505315052019-03-06
10381780486978MediHoney®31805318052018-09-14
00386190002056MicroMatrix®MMFX05MMFX052023-10-02
00386190001820Cytal®WSR1625WSR16252019-12-16
00386190001837Cytal®WSR1635WSR16352019-12-16
00386190000007MatriStemMM0020MM00202017-01-10
00386190000014MatriStemMM0030MM00302017-01-10
00386190000052MatriStemWS0303WS03032017-01-10
00386190000076MatriStemWS0307WS03072017-01-10
00386190000090MatriStemWS0710WS07102017-01-10
00386190000113MatriStemWS1015WS10152017-01-10
00386190000137MatriStemMM0060MM00602017-01-10
00386190000151MatriStemMM0100MM01002017-01-10
00386190000168MatriStemMM0100FMM0100F2017-01-10
00386190000182MicroMatrix®MM0200MM02002017-01-10
00386190000199MatriStemMM0200FMM0200F2017-01-10

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04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
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10884389161562MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-06
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