FDA.reportPublic FDA data

MEDSAF Roll 10 x 99cm

Primary DI
05060188824275
Brand
MEDSAF Roll 10 x 99cm
Company
MANUKAMED LIMITED PARTNERSHIP
Model
MM0122
Published
2019-05-24
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
FRLFiber, Medical, Absorbent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060188824275PrimaryGS10
05060188824268Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060188824275050601888242755060188824275
05060188824268050601888242685060188824268

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gelA sterile wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
594970245
Device count
4
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
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
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

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