FDA.reportPublic FDA data

L-Mesitran Tulle

Primary DI
08717249680833
Brand
L-Mesitran Tulle
Company
Theo Manufacturing B.V.
Model
318.10.US
Device description
L-Mesitran Tulle are wound dressings for the use on wounds. L-Mesitran Tulle is a non-adherent polyethylene dressing impregnated with L-Mesitran Soft gel.
Published
2023-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K150676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150676000L-Mesitran Dressing Family II- Soft and TulleTheo Manufacturing BV2015-12-23FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717249680833PackageGS110In Commercial Distribution
08717249680505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717249680833087172496808338717249680833
08717249680505087172496805058717249680505

GMDN Terms#

Term, Definition table
TermDefinition
Medical honey liquid barrier dressingA material formed from medical grade honey intended to protect wounds or tissue surfaces by providing a non-occlusive external barrier to bacteria and the environment. It also helps to maintain a moist internal environment for wounds to assist the healing process. The material may be liquid or semi-liquid and is typically applied directly to the wound or tissue surface (e.g., ocular surface). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch
Width4Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
408656143
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717249680505L-Mesitran Tulle318.10.US2023-03-17
08717249680727L-Mesitran Active511.052023-03-17
08717249680758L-Mesitran Hydro418.10.US2023-03-17
08717249680765L-Mesitran Border518.10.US2023-03-17
87172496807278L-Mesitran Active511.052023-03-17
08717249680734L-Mesitran Soft 0.5oz203.01.US2023-03-17
08717249680741L-Mesitran Soft 1.75oz205.01.US2023-03-17
08717249680840L-Mesitran Hydro418.10.US2023-03-17
08717249680857L-Mesitran Border518.10.US2023-03-17

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