FDA.report

Lyofoam® Max T

Primary DI
07332551992170
Brand
Lyofoam® Max T
Company
Mölnlycke Health Care AB
Model
603207
Device description
Lyofoam Max T 9cmx9cm x 10pcs
Published
2022-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NACDressing, wound, hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07332551992163PackageGS16In Commercial Distribution
07332551992170PackageGS110In Commercial Distribution
07332551999759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07332551992163073325519921637332551992163
07332551992170073325519921707332551992170
07332551999759073325519997597332551999759

GMDN Terms

TermDefinition
Tracheostomy tube dressingA pad designed to conform around a tracheostomy tube at its insertion site to provide protection for the skin and/or to absorb secretions. It is typically designed with a slit or hole to facilitate tube fitting. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+46737733775pedro.lopes@molnlycke.com

Regulatory Flags

DUNS number
631770658
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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