FDA.reportPublic FDA data

First Honey Sterile Honey Ointment (1.0 Oz)

Primary DI
00854056008004
Brand
First Honey Sterile Honey Ointment (1.0 Oz)
Company
MANUKAMED LIMITED PARTNERSHIP
Model
FH0049
Published
2020-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K092689000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092689000MANUKAPLI WOUND DRESSINGManuka Medical Limited2010-05-20FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854056008004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854056008004008540560080048540560080040854056008004

GMDN Terms#

Term, Definition table
TermDefinition
Medical-honey liquid barrier dressing, sterileA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
594970245
Device count
1
Combination product
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060188820062Gentell Manuka Honey Fiber Select 2" x 2" (formerly MANUKAhd Lite)MM00302020-05-14
05060188820109Gentell Manuka Honey Fiber Select 4" x 5" (formerly MANUKAhd Lite)MM00312020-05-14
05060188820468Gentell Manuka Honey Non-Adherent Dressing 4" x 5" (formerly MANUKAtex)MM00102020-05-14
05060188820529Gentell Manuka Honey Non-Adherent Wrap 4" x 48" (formerly MANUKAtex)MM00122020-05-14
05060188820581Gentell Manuka Honey Fiber Premium 2" x 2" (formerly MANUKAhd)MM00132020-05-14
05060188820741Gentell Manuka Honey Fiber Premium 4" x 5" (formerly MANUKAhd)MM00172020-05-14
05060188821250Gentell Manuka Honey Fiber Dressing 4" x 5" (formerly MANUKAhd Super Lite)MM00712020-05-14
05060188822325Gentell Manuka Honey Wound Dressing 15g (formerly MANUKApli 15g)MM00492020-05-14
05060188822387Gentell Manuka Honey Wound Dressing 44g (formerly MANUKApli 44g)MM00512019-05-24
05060188821205Gentell Manuka Honey Fiber Dressing 2" x 2" (formerly MANUKAhd Super Lite)MM00702019-01-30
00854056008011First Honey Sterile Honey Ointment (0.5 Oz)FH00522020-05-14
00854056008134First Honey Sterile Honey Ointment (1.0 Oz)FH0049D2020-05-14
05060188820147MANUKAhd Lite Border 10 x 10 cmMM00322019-01-28
05060188824190MEDSAF 10 x 12.5cmMM01212020-05-14
05060188823735MEDSAF 5 x 5cmMM01202019-09-19
05060188824275MEDSAF Roll 10 x 99cmMM01222019-05-24
05060188821403MANUKAhd SuperLite RollsMM00742019-05-24
00854056008035First Honey Manuka BandagesFH01602020-05-14
00854056008042First Honey Manuka DressingsFH01612020-05-14
05060188820055MANUKAhd Lite 5 x 5 cmMM00302020-05-14

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