FDA.reportPublic FDA data

LMP Manuka Fill

Primary DI
00851028001094
Brand
LMP Manuka Fill
Company
LINKS MEDICAL PRODUCTS INC
Model
WC05
Catalog number
WC05
Device description
Wound dressing consisting of 100% Manuka Honey in a 1.5 oz tube.
Published
2024-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
K131796000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131796000MANUKA FILL WOUND DRESSINGLinks Medical Products, Inc.2014-03-14FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851028001094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851028001094008510280010948510280010940851028001094

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1.5Fluid Ounce

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry; Do not use if package is damaged; Keep out of direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-753-0001info@linksmed.com

Regulatory Flags#

DUNS number
839081445
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851028001100LMP Manuka FillWC07WC072024-01-12
00851028001162LMP Manuka IGWC20WC202024-01-12
00851028001353LMP Manuka IG MaxWC25WC252024-01-12
00851028001377LMP Manuka IG Max RopeWC37WC372024-01-12
00851028001407LMP Manuka Foam AirWC70WC702024-01-12
10851028001107LMP Manuka FillWC07WC072024-01-12
10851028001169LMP Manuka IGWC20WC202024-01-12
10851028001350LMP Manuka IG MaxWC25WC252024-01-12
10851028001374LMP Manuka IG Max RopeWC37WC372024-01-12
10851028001404LMP Manuka Foam AirWC70WC702024-01-12
00851028001391LinkTempLMP001LMP0012016-10-24

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