FDA.reportPublic FDA data

Gentell Manuka Honey Fiber Dressing 4" x 5" (formerly MANUKAhd Super Lite)

Primary DI
05060188821250
Brand
Gentell Manuka Honey Fiber Dressing 4" x 5" (formerly MANUKAhd Super Lite)
Company
MANUKAMED LIMITED PARTNERSHIP
Model
MM0071
Published
2020-05-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
05060188821250PrimaryGS10
05060188821243Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060188821250050601888212505060188821250
05060188821243050601888212435060188821243

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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
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
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00850039735370TG-32 Antimicrobial Wound GelSilverceuticals IncFRO2026-10-26
00850039735387TG-32 Antimicrobial Wound GelSilverceuticals IncFRO2026-10-26
00850039735394MendER Antimicrobial Wound GelSilverceuticals IncFRO2026-10-26
00197998307386Solventum™ Actisorb™ Silver 220Solventum Germany GmbHFRO2026-10-22
00197998307423Solventum™ Actisorb™ Silver 220Solventum Germany GmbHFRO2026-10-22
00197998307461Solventum™ Actisorb™ Silver 220Solventum Germany GmbHFRO2026-10-22
10080196299850MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-10-22
00818582013628Puracyn Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.FRO2026-10-16
05059884011164Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011171Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
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05059884011218Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
05059884011225Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111385Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
00050428034712CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09