FDA.reportPublic FDA data

ManukaMed Adhesive Dressings

Primary DI
05060188820239
Brand
ManukaMed Adhesive Dressings
Company
MANUKAMED LIMITED PARTNERSHIP
Model
MM0161
Device description
"A unit carton of six 3"" x4"" Manuka Honey coated adhesive island wound dressings"
Published
2020-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K102659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102659000MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDERManuka Medical Limited2010-12-08FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060188820239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060188820239050601888202395060188820239

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). 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
00854056008004First Honey Sterile Honey Ointment (1.0 Oz)FH00492020-05-14
00854056008011First Honey Sterile Honey Ointment (0.5 Oz)FH00522020-05-14
00854056008134First Honey Sterile Honey Ointment (1.0 Oz)FH0049D2020-05-14
05060188822325ManukaPli Sterile Honey Ointment (15g)MM00492020-05-14
05060188822387ManukaPli 44geMM00512019-05-24
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
05060188820062MANUKAhd Lite 5 x 5 cmMM00302020-05-14
05060188820109MANUKAhd Lite 10 x 12.5 cmMM00312020-05-14
05060188820468MANUKAtex 10 x 12.5 cmMM00102020-05-14
05060188820529MANUKAtex 10 x 122 cmMM00122020-05-14
05060188820581MANUKAhd Lite 5 x 5 cmMM00132020-05-14
05060188820741MANUKAhd 10 x 12.5 cmMM00172020-05-14
05060188821250MANUKAhd Super Lite 10 x 12.5 cmMM00712020-05-14
05060188821403MANUKAhd SuperLite RollsMM00742019-05-24
05060188821205MANUKAhd Super Lite 5 x 5 cmMM00702019-01-30
00854056008035First Honey Manuka BandagesFH01602020-05-14
00854056008042First Honey Manuka DressingsFH01612020-05-14

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