FDA.reportPublic FDA data

MediHoney®

Primary DI
10381780486886
Brand
MediHoney®
Company
ACELL, INC.
Model
31815
Catalog number
31815
Device description
MEDIHONEY® Gel Dressing with Active Leptospermum Honey Wound & Burn Dressing
Published
2018-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780486880PackageGS112In Commercial Distribution
10381780486886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038178048688030381780486880
1038178048688610381780486886

GMDN Terms#

Term, Definition table
TermDefinition
Medical honey liquid barrier dressingA 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
Total Volume1.5Fluid Ounce
Total Volume44Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+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
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
00386190000212MatriStemMM0500MM05002017-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28
10841495149815QUIKCLOTTELEFLEX INCORPORATEDFRO2026-07-27
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
B665AVX030011VIA LinxArch Therapeutics, Inc.FRO2026-07-24
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08