FDA.reportPublic FDA data

First Honey Manuka Bandages

Primary DI
00854056008035
Brand
First Honey Manuka Bandages
Company
MANUKAMED LIMITED PARTNERSHIP
Model
FH0160
Device description
A unit carton of 12 Bandages.
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
00854056008035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854056008035008540560080358540560080350854056008035

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
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
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
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
00854056008042First Honey Manuka DressingsFH01612020-05-14
05060188820055MANUKAhd Lite 5 x 5 cmMM00302020-05-14

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