FDA.reportPublic FDA data

MANUKAhd 10 x 12.5 cm

Primary DI
05060188820741
Brand
MANUKAhd 10 x 12.5 cm
Company
MANUKAMED LIMITED PARTNERSHIP
Model
MM0017
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
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
05060188820741PrimaryGS10
05060188820734Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060188820741050601888207415060188820741
05060188820734050601888207345060188820734

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, antimicrobialA wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
594970245
Device count
10
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
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
05060188820055MANUKAhd Lite 5 x 5 cmMM00302020-05-14

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00850087488747CeeportCEEPORT INC.FRO2026-08-25
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05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
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00197998432385Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
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00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
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10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
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