FDA.reportPublic FDA data

MANUKAtex 10 x 122 cm

Primary DI
05060188820529
Brand
MANUKAtex 10 x 122 cm
Company
MANUKAMED LIMITED PARTNERSHIP
Model
MM0012
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
K110042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110042000MANUKATEXManuka Medical Limited2011-03-24FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060188820529PrimaryGS10
05060188820512Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060188820529050601888205295060188820529
05060188820512050601888205125060188820512

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin, and that contains an antimicrobial agent (e.g., silver (Ag), honey). Its pores permit the drainage of exudates from, and application of medication to, the wound. This device may be used with other wound-care products to help heal chronic/infected and postoperative wounds, burns, skin grafts, cuts, or abrasions; it is not a dedicated burn dressing. This is a single-use device.

Regulatory Flags#

DUNS number
594970245
Device count
4
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
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
05060188820055MANUKAhd Lite 5 x 5 cmMM00302020-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781550GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781574GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169443MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169474MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169481MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169498MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169504MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344170197MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-10-13
10192253046274KendallCardinal Health 200, LLCFRO2025-09-22
10192253047837XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047844XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047851XeroformCardinal Health 200, LLCFRO2025-09-22